Midweek update

U.S. Healthcare

Midweek update

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate approved a sweeping defense-policy package despite alarm over a provision that rolls back safety measures put in place following the fatal midair collision in January between a military helicopter and passenger plane at Ronald Reagan Washington National Airport. 
    • “The Senate passed the $901 billion National Defense Authorization Act on a vote of 77-20, codifying more than a dozen of President Trump’s executive orders, while placing new limits on his ability to act unilaterally overseas. The House passed the annual measure last week 312 to 112, and it now goes to Trump’s desk for his signature.
    • “While the bill sets specific spending levels for the Pentagon, it doesn’t appropriate any money, which is done through separate legislation. Lawmakers added $8 billion to the Pentagon’s budget request. The legislation would increase America’s total national-security budget by less than 1% from last year’s $895 billion authorization bill. It also raises troop pay 3.8%.”
  • Fierce Healthcare adds,
    • “Nearly two years after its introduction as a bill during the last U.S. Congress, the Biosecure Act has survived an election and a presidential transition and appears poised to become law. But this version, tucked into the nation’s annual defense bill, features some changes from the first iteration.
    • “Both the House of Representatives and the Senate have passed the $901 billion defense bill, sending it to the president’s desk for a signature. The White House has said President Donald Trump plans to sign the massive defense package, Reuters reports.
    • “Within the mammoth bill, the Biosecure Act has the potential to raise new hurdles for certain life sciences companies from China, as well as their partners, although the exact effects of the legislation remain tough to fully assess at this stage.”
  • STAT News tells us,
    • “House Republicans on Wednesday passed a health care bill aimed at lowering health care costs and providing more options for employer-provided health insurance.” * * *
    • “The Lower Health Care Premiums for All Americans Act would expand access to association health plans by allowing small employers and self-employed individuals to band together across industries to buy insurance that is less regulated. Large employers already can offer this kind of coverage. About 700,000 more people per year on average would choose association health plans under the bill, about 200,000 of whom currently don’t have insurance, according to the nonpartisan Congressional Budget Office.” * * *
    • “Another measure would prevent states from regulating stop-loss insurance that self-insured plans use to protect against large claims to control costs. 
    • “It also would fund cost-sharing reductions for low-income enrollees in the Affordable Care Act marketplace. Funding cost-sharing reductions would lower gross premiums for benchmark silver plans by 11% on average, according to the CBO. Because ACA subsidies are based on the cost of a silver plan, that lowers the amount of tax credits available to buy any plan.” 
  • The Wall Street Journal further reports,
    • “Four vulnerable House Republicans rebelled against Speaker Mike Johnson (R., La.) and backed a Democratic effort to force a vote on extending Affordable Care Act subsidies, exposing GOP fractures over surging healthcare costs headed into next year’s midterm elections.” * * *
    • “With the GOP signatures on the discharge petition, Jeffries now has the 218 needed to force a vote, which wouldn’t likely occur until after the holiday break. But the centrists’ move could keep up pressure on both parties to reach a deal, and talks were continuing in the Senate on a possible compromise for early in the new year.
    • “The defections delivered a blow to Johnson’s leadership in the House, where he has been forced to manage a historically narrow majority—currently 220-213—that gives any small bloc of Republicans power to derail or hijack his agenda.
    • “We’re keeping a productive conversation going,” Johnson told reporters after the defectors signed onto the Democratic plan. “I have not lost control of the House.”
  • STAT News tells us,
    • “Several drugmakers are expected to sign pricing agreements with the Trump administration on Friday, according to four people familiar with the plans, who were not authorized to speak publicly.
    • “The agreements would be the latest in a series of deals in which pharmaceutical companies agree to lower drug prices and invest more domestically in exchange for avoiding tariffs and other benefits, such as fast-tracked drug reviews.”
  • An OPM Inspector General data brief lets us know that following an OPM mandate in January 2023, spending on GLP-1 drugs in the FEHB Program for the treatment of obesity surged dramatically. While OPM has the authority to make unilateral amendments to their FEHB and PSHB contracts with carriers, the carriers have a right to an equitable price adjustment. See Section 5.38 of the standard OPM contracts. The only way to achieve is an equitable price adjustment (or any price adjustment for that matter) is through the annual benefit and rate proposal process. OPM should have proposed the change for 2024, and then allowd the carriers to include the cost of these drugs in their 2024 premium. OPM didn’t do this. and this mistake caused FEHB premiums to jump more than they should have in 2025. This should be the lesson taken from this data brief.
  • Govexec informs us,
    • “The U.S. Postal Service on Wednesday announced plans to expand access to its last-mile delivery network, which the new postmaster general hopes will provide a boon to the financially struggling agency. 
    • “In the logistics business, the most expensive part of delivery is generally the ‘last mile’ portion of a route. As part of our universal service obligation, we deliver to more than 170 million addresses at least six days a week, so we are the natural leader in last-mile delivery,” Steiner said in a statement. “We want to make this valuable service available to a wide range of customers that see the worth of last mile access — other logistics companies and retailers large and small.” 
    • “USPS in late January or early February 2026 will begin auctioning off access to more than 18,000 delivery destinations, according to a press release. 
    • “Steiner said in an interview with Reuters about the program that it could raise billions in revenue for USPS, which is needed as the PG also warned that the agency could run out of money in early 2027.”
  • Federal News Network interviews NARFE’s Staff Vice President for Policy and Programs John Hatton.
    • Federal employees are seeing signs of stability. Retirement processing is improving, workforce protections are holding, and pay raise prospects are clearer. But with continuing resolutions and hiring freezes still in the mix, the path forward requires careful planning. What can be expected in the coming year?
  • Mercer informs us,
    • “Starting next July, employers can voluntarily contribute to the Trump accounts of employees’ dependent children. Created by the One Big Beautiful Bill Act (Pub. L. No. 119-21), these accounts are a new kind of tax-preferred savings vehicle for individuals under 18. Employer contributions up to $2,500 per year are excludable from an employee’s gross income if made pursuant to a program that meets certain conditions. This tax exclusion also applies to employer contributions to accounts of employees who are under 18. Originally published on Aug. 5, 2025, this article has been updated to reflect IRS guidance in Notice 2025-68. IRS intends to propose regulations consistent with the guidance in the notice. IRS is accepting comments on the notice through Feb. 20, 2026.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With a fresh endorsement from the FDA, the last of five major drug approvals has fallen into place for GSK in 2025.
    • “Tuesday, the U.S. regulator greenlit GSK’s depemokimab, an ultra-long-acting biologic, as a new add-on maintenance therapy for severe asthma with an eosinophilic phenotype in patients ages 12 and older. The drug will hit the market under the Exdensur brand name, GSK said in a Dec. 16 press release.
    • “GSK has drafted lofty sales ambitions for Exdensur, an IL-5 antagonist that is injected just twice a year. The British pharma has previously estimated the inflammatory disease med could reel in sales of 3 billion pounds sterling ($4 billion) at peak.”
  • BioPharma Dive informs us,
    • “DBV Technologies shares soared Wednesday after the company said its Viaskin peanut allergy patch succeeded in a Phase 3 trial.
    • “The results represent a comeback for the patch, which was rejected by the Food and Drug Administration in August 2020. At the time, regulators said the patch needed modifications to fully adhere to the skin and called for more data to support its efficacy.
    • “With the results of the trial, dubbed Vitesse, in hand, DBV now plans to submit an application to the FDA in the first half of next year to clear the patch for children between the ages of 4 and 7. The FDA has previously awarded the treatment a breakthrough therapy designation, and it may qualify for a priority review, DBV said Tuesday.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) said the United States has tracked 1,958 measles cases so far this year, nearing the 2,000-case milestone just one month before the country will likely lose its elimination status. 
    • “The total represents 46 new US cases.
    • “There have been 49 US outbreaks reported in 44 US jurisdictions, the CDC said, as well as 24 measles cases reported among international visitors to the United States. Eighty-eight percent of all measles cases reported this year have been outbreak-associated. 
    • “Among US cases, 26% are in children under the age of 5 years, 41% of patients are between 5 and 19 years, 32% are 20 years or older, and 1% have unknown ages. Ninety-three percent of case-patients are unvaccinated or have unknown vaccination status, while 3% have one dose of measles-containing vaccine, and 4% are fully vaccinated. 
    • “So far, 222 people (11%) have been hospitalized for measles infections in the United States this year, and three have died.”
  • and
    • “Two studies on respiratory syncytial virus (RSV) protection conclude that vaccine effectiveness against infection and related health care use drops over 18 months in US veterans and that the effectiveness of the long-acting monoclonal antibody preventive nirsevimab is strong in hospitalized European children younger than two years but wanes over seven months.
    • “Older adults and infants are especially vulnerable to severe RSV, with possible complications of bronchiolitis, pneumonia, and sepsis.” * * *
    • “In an editorial in the same journal, Editorial Fellow Anna Hung, PhD, of Duke University, and Associate Editor Lona Mody, MD, of the University of Michigan, noted that, despite the Centers for Disease Control and Prevention’s recommendation for a single dose for anyone aged 75 and older and those aged 60 to 74 years at increased risk for severe disease, less than half of either group receives the vaccine.
    • “This low uptake can be explained by various reasons including relative recency of development of the vaccine, lack of awareness of the seriousness and frequency of RSV infection, a hazy shared clinical decision-making model, access barriers, a general vaccine fatigue, and lack of clear guidance to clinicians,” they wrote. 
    • “They added that the greater decline in VE among immunocompromised veterans suggests the need for RSV boosters. “Experts will need to evaluate this evidence carefully to update guidance,” they wrote.”
  • The American Hospital Association News lets us know, “Depression and anxiety can increase the risk of a major adverse cardiac event, according to an American Heart Association study published Dec. 17.”
  • Health Day relates,
    • “Adherence to cervical cancer screening guidelines is low, with more than 60 percent undergoing overscreening, according to a research letter published online Dec. 10 in JAMA Network Open.
    • “Michelle B. Shin, Ph.D., M.P.H., R.N., from the University of Washington in Seattle, and colleagues examined cervical cancer screening guideline adherence among a nationally representative commercially insured cohort to assess factors and modalities associated with nonadherence. Data were analyzed from the 2013 to 2021 Optum Clinformatics anonymized longitudinal claims database covering about 13 million individuals annually.
    • “The researchers found that among 670,003 eligible individuals, 47.1 and 52.9 percent received cytology alone and cotesting, respectively. Overall, only 7.3 percent were guideline-adherent, while 61.6 and 31.1 percent were overscreened and underscreened, respectively.”
    • * * * “Consistent with prior work, we observed low adherence (7.3 percent) to cervical cancer screening guidelines among the commercially insured U.S. population despite stable coverage, likely reflecting guideline confusion among patients, clinicians, and health systems,” the authors write.”
       
  • Per the University of Minnesota’s CIDRAP,
    • “Treatment with the antiviral combination nirmatrelvir–ritonavir (Paxlovid) was associated with fewer lost workdays and lower disability-related costs among US employees at high risk for severe COVID-19, according to a retrospective observational study in the Journal of Medical Economics.
    • “Using insurance claims and workplace productivity data from large US employers, the researchers, led by scientists from Paxlovid maker Pfizer, compared productivity outcomes among high-risk employees diagnosed as having COVID who either received Paxlovid within five days of diagnosis or received no antiviral. 
    • “Analyses of absences among treated and untreated workers and those on short-term disability (STD) and long-term disability (LTD) included 1,909, 20,065, and 20,318 employees, respectively. The study included data from December 2021 through December 2022, a period dominated by Omicron variants.”
  • Per Fierce Pharma,
    • “The combination of Keytruda and Padcev is taking another major step toward securing its position as a leading therapy in the treatment of bladder cancer.
    • “The PD-1/antibody-drug conjugate pairing significantly extended the lives of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy compared with chemotherapy, according to results from the phase 3 Keynote-B15 (EV-304) trial. The study evaluated Keytruda and Padcev, given both before and after surgery in what’s known as a perioperative treatment, and compared the regimen with neoadjuvant chemotherapy followed by surgery.
    • “Keytruda developer Merck & Co. sponsored the study in collaboration with Padcev makers Astellas and Pfizer. The three firms announced the positive top-line readout from an interim analysis Wednesday.”
  • and
    • “Armed with new three-year data demonstrating the benefits of Anktiva in a specific patient subset, ImmunityBio is proving its bladder cancer med is still one to watch as it competes with heavy hitters from Merck and Johnson & Johnson.
    • “Last year, the company won a long-sought FDA approval for its drug—used alongside the Bacillus Calmette-Guérin (BCG) vaccine—to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. 
    • “That nod set up a showdown with Merck’s Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin. More recently, the competition has amped up, with Johnson & Johnson’s Inlexzo hitting the scene and putting pressure on IL-15 receptor agonist Anktiva.
    • “Not deterred by the expanding competitive landscape, ImmunityBio is using new data from the company’s Quilt-3.032 study to flesh out Anktiva’s benefits in patients with BCG-unresponsive high-grade papillary-only NMIBC. Papillary tumors and CIS are the two clonally linked subtypes of NMIBC, ImmunityBio explained in a Dec. 16 press release. 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Oscar Health, Angle Health, Curative, Centivo and Sidecar Health are testing the market for alternative health plans.
    • “Options such as variable copay plans and individual coverage health reimbursement arrangements may appeal to employers seeking to cut costs.
    • “Leading insurers such as UnitedHealthcare, Aetna, Cigna, and Blue Cross and Blue Shield companies are active in this market.
    • “More than one-third of large businesses will offer nontraditional health benefits in 2026, according to Mercer.”
  • Fierce Healthcare relates,
    • “Cigna’s Evernorth launched a behavioral-health-focused medical group in 2024 to meet the demand for behavioral health therapy and support.
    • “In the past 18 months, Evernorth has expanded its Behavioral Care Group from virtual services in six markets and a network of 1,000 providers to more than 5,000 providers across all 50 states.
    • “Evernorth now plans to grow the medical group to more than 15,000 providers next year.
    • “The medical group also now offers in-person appointments to complement its virtual care services. Evernorth executives say this hybrid approach allows patients to choose the care setting that best suits their needs without compromising on quality or convenience.”
  • BioPharma Dive points out,
    • “Biotechnology startup Orum Therapeutics has banked 146 billion Korean won, or about $100 million, to fuel development of medicines that merge elements of two popular drugmaking approaches.
    • “Orum on Thursday said that proceeds from the round — which was led by KB Investments and involved seven other firms — will help advance a potential acute myeloid leukemia drug called ORM-1153 and that recently became its top candidate.
    • “The startup, which has offices in Cambridge, Massachusetts, and Daejeon, South Korea, is developing what are known as “degrader-antibody conjugates.” These drugs are a twist on the antibody-drug conjugates, or ADCs, used to treat multiple cancers. ADCs link a targeting molecule to a tumor-killing toxin. Orum’s drugs, by comparison, use a protein-degrading compound as a payload.”
  • Per Axios,
    • “Employer-sponsored insurance may be getting costlier, but it still delivers a positive return for firms that cover their workers, according to a new Avalere Health analysis commissioned by the U.S. Chamber of Commerce and provided first to Axios.
    • “Why it matters: Workplace insurance is the backbone of the American health care system, covering around half of the population. Whether it’s a well-functioning system or not, workers and families depend on it.
    • “What they found: The analysis measured what companies get back from each dollar invested in health benefits and concluded benefits exceeded costs for firms of all sizes this year, and that ROI will only grow through 2029.
    • “Employer insurance will yield an estimated 120% ROI to employers in the aggregate in 2025 and a 137% return in 2029, per the analysis.
    • “That comes from increased productivity, tax benefits and increased retention.”

Tuesday report

David Ermer–ACA, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • Politico reports,
    • “A bipartisan group of nearly two dozen senators huddled Monday night to work out an 11th-hour health care deal to extend Affordable Care Act insurance subsidies set to expire at the end of this month.
    • “At a meeting convened by Sens. Susan Collins (R-Maine) and Bernie Moreno(R-Ohio), the senators discussed a two-year extension of the Obamacare tax credits that would be coupled with a new income eligibility cap and fraud prevention language.
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said Congress won’t be able to extend federal health-insurance subsidies before leaving for the holidays, ending hopes for a last-minute deal and punting any possible fix into the new year.
    • “We’re not going to pass anything by the end of this week, but I do think there’s a potential pathway in January,” Thune said at a press conference on Tuesday. Lawmakers are expected to depart Washington before the weekend and won’t return until Jan. 5.” * * *
    • “House Republicans still are expected to pass a GOP healthcare bill on Wednesday that would expand access to association health plans, which generally allow small employers to band together and provide health insurance, and appropriate money to fund the cost-sharing reductions that reduce out-of-pocket spending for lower-income ACA enrollees. It doesn’t include any ACA extensions or the health savings accounts favored by many Republicans. 
    • “The Congressional Budget Office said the bill would reduce the federal deficit by $35.6 billion over a decade, but it would also reduce the number of people with health insurance by an average of 100,000 a year.” 
  • OPM Director Scott Kupor added a post about the new U.S. Tech Force to his Secrets of OPM blog today.
  • Federal News Network adds,
    • “Agencies will soon see a more streamlined process for potentially offering higher-value bonuses to federal employees who are being hired or relocated.
    • “A new final rule from the Office of Personnel Management on Tuesday seeks to reduce “administrative burden” and “increase efficiency” in the process for approving recruitment and relocation incentives. The changes come after OPM first proposed regulations in November 2023.
    • “In practice, OPM’s changes will shift the transactional work of approving waivers for larger bonuses off of OPM’s plate, and instead make it the responsibility of individual agencies. The goal is make the process for offering pay incentives easier, and in theory free up time for OPM to focus on other priorities, according to the final rule.”
  • HHS Assistant Secretary for Technology Steve Posnak remarks in his agency’s HealthBuzz blog
    • In July the Centers for Medicare & Medicaid Services (CMS) launched an ambitious Health Technology Ecosystem pledge program. The groundswell of energy and enthusiasm for the program has been remarkable, and we’re glad to be their partner. CMS established several pledge categories associated with aspirational criteria included within its CMS Interoperability Framework. This [HealthBuzz] post looks specifically at the similarities and differences between the Trusted Exchange Framework and Common Agreement™ (TEFCA™) and the “CMS-Aligned Network” pledge category.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Harvey Risch, M.D., Ph.D., as chairman of the President’s Cancer Panel. The panel, part of the National Institutes of Health’s (NIH) National Cancer Institute, is charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the president on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.”
  • Per a GAO news release,
    • “Congress created USPS to be financially self-sufficient. However, USPS has lost billions since 2007 as people use mail less and costs increase. As a result, USPS’s financial viability has been on our High Risk list since 2009.
    • “USPS has tried to improve financially by raising prices and making operational changes. Congress also passed legislation to reduce some of USPS’s expenses. More must be done. But USPS hasn’t projected how its changes, like transporting more mail on trucks, may affect its future revenue, expenses, and more. USPS and Congress need these projections to determine what other steps to take. Our recommendation addresses this.”

From the Food and Drug Administration front,

  • Biopharma Dive reports,
    • “The Food and Drug Administration on Monday granted a key approval for AstraZeneca and Daiichi Sankyo’s Enhertu, clearing a regimen involving the drug as an initial treatment for HER2-positive breast cancer. 
    • “The approval issued Monday comes well ahead of the FDA’s Jan. 23 decision deadline and greenlights a combination of Enhertu and Roche’s targeted therapy Perjeta for frontline use in people whose metastatic breast cancer is confirmed to be HER2-positive by an FDA-approved test. The clearance is based on results published in the New England Journal of Medicine earlier this year, which showed the Enhertu-Perjeta regimen was more beneficial than the current first-line standard, a combination of chemotherapy and precision drugs that’s known as THP.” 
  • MedTech Dive notes,
    • “The Food and Drug Administration received more than 100 comments after seeking responses on how to monitor the real-world performance of artificial intelligence in medical devices. 
    • “The feedback diverged, with patients calling for stronger postmarket reporting and medical groups saying reporting should be the responsibility of manufacturers. Device companies, meanwhile, called for the FDA to use its existing regulatory frameworks instead of introducing new requirements.
    • “The FDA’s emphasis on real-world performance comes as the agency considers how to regulate increasingly complex technologies, such as generative AI, and how to ensure the performance of AI models doesn’t degrade over time.” 

From the public health and medical / Rx research front,

  • Per HHS news releases,
    • “The U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today approved the addition of Duchenne Muscular Dystrophy (DMD) and Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP) following scientific review and public comment. Early detection of both conditions allows children to receive FDA-approved therapies at the most effective time, helping to slow disease progression and preserve their quality of life.
    • “As my uncle has said, ‘although children may be the victims of fate, they will not be the victims of our neglect,’” said Secretary Kennedy. “This action honors that principle. Early screening gives every child a fair chance at timely, effective care, and it delivers families the answers and treatment options they deserve—right when they need them most.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age.” * * *
    • “The CDC is reviewing ACIP’s secondary recommendation that parents should consult with a health care provider on serology testing to determine whether a subsequent hepatitis B vaccine dose is needed. For infants born to mothers who test positive for hepatitis B or whose status is unknown, the currently recommended birth dose of hepatitis B vaccine and immunoglobulin continues with no change.
    • “The adoption of individual-based decision-making for hepatitis B immunization maintains consistency of coverage through all payment mechanisms, including entitlement programs such as the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.
    • “Fact Sheet: Hepatitis B Immunization“
  • Per MedTech Dive,
    • “The Centers for Medicare and Medicaid Services will reconsider its national coverage determination for transcatheter aortic valve replacement in response to a request from Edwards Lifesciences, according to an agency posting on Monday.
    • “Edwards, in a July letter, asked the agency to reconsider its current policy for TAVR patients who are Medicare beneficiaries to reflect new evidence demonstrating improved outcomes when the valves are used to treat asymptomatic patients. Those patients are currently beyond the scope of Medicare coverage for the treatment.
    • “Analysts expect expanded Medicare coverage to drive further adoption of TAVR. William Blair analyst Brandon Vazquez said one-third of severe aortic stenosis patients are estimated to be asymptomatic. Broader reimbursement could also prompt more hospitals to open TAVR centers, Vazquez said.”
  • The New York Times reports,
    • “For a while, it seemed the notion that light drinking was good for the heart had gone by the wayside, debunked by new studies and overshadowed by warnings that alcohol causes cancer.
    • “Now the American Heart Association has revived the idea in a scientific review that is drawing intense criticism, setting off a new round of debate about alcohol consumption.
    • “The paper, which sought to summarize the latest research and was aimed at practicing cardiologists, concluded that light drinking — one to two drinks a day — posed no risk for coronary disease, stroke, sudden death and possibly heart failure, and may even reduce the risk of developing these conditions.
    • “Controversy over the influential organization’s review has been simmering since it was published in the association’s journal Circulation in July.”
  • Per Fierce Pharma,
    • “With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.
    • “In Gilead’s Artistry-2 study, the company’s single-tablet regimen of bictegravir and lenacapavir matched up to Gilead’s own megablockbuster HIV medicine Biktarvy when assessing patients’ treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.”
  • Per MedPage Today,
    • “More than 70% of patients with advanced triple-negative breast cancer (TNBC) responded to an investigational bispecific antibody targeting PD-L1 and VEGF-A plus chemotherapy, a preliminary study showed.
    • “Overall, 71.8% (61.5% confirmed) of patients had partial responses to either of two dose levels of pumitamig plus nab-paclitaxel (Abraxane), and 23.1% had stable disease, resulting in a disease control rate of 94.9%. Tumor shrinkage occurred in all but five evaluable patients, averaging 42.6% for the entire cohort.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “With COVID sales falling and patent protections expiring, Pfizer is forecasting its 2026 revenue to be in the range of $59.5 billion to $62.5 billion. The midpoint of the projection ($61 billion) would be a decline from this year’s estimated revenue of $62 billion—which the company reaffirmed on Tuesday. It would also be an additional slide from Pfizer’s 2024 revenue of $63.6 billion.
    • “Built into the 2026 guidance is a $1.5 billion decline in sales of its COVID products—from an estimated $6.5 billion this year to $5 billion in expected sales next year. The company also expects to sustain a $1.5 billion hit from the loss of exclusivity (LOE) of its products.
    • “As those LOEs escalate in the coming years—to $3 billion-plus in 2027 and $6-plus in 2028—the drugmaker said that it doesn’t expect to see growth until 2029.”
  • Modern Healthcare relates,
    • “Medline Inc. raised $6.26 billion in the year’s biggest initial public offering, upsizing the deal and pricing the shares near the top of the marketed range.
    • “The company sold 216 million shares Tuesday for $29 each, according to a statement confirming a Bloomberg News report. Medline, which counts Blackstone Inc., Carlyle Group Inc. and Hellman & Friedman among its backers, had marketed 179 million shares for $26 to $30 each.
    • “The pricing gives the company a market value of about $39 billion, based on the number of shares listed in its filings with the U.S. Securities and Exchange Commission.
    • “Medline manufactures and distributes medical supplies such as gloves, gowns and exam tables used by hospitals and doctors. The three private equity firms sealed a $34 billion deal to acquire a majority stake in the company in 2021, in one of the largest leveraged buyouts of all time.” 
  • and
    • “City of Hope has opened Orange County’s first hospital exclusively dedicated to cancer care, marking a major milestone in the organization’s commitment to increasing access to advanced cancer treatment and research across the country. 
    • “The cancer specialty hospital, which began seeing patients Dec. 1, sits on City of Hope Orange County’s 72-acre academic campus in Irvine, California, and is connected to City of Hope Orange County Lennar Foundation Cancer Center, which opened in 2022. The opening completes a full continuum of cancer services in the region, enabling patients to access advanced inpatient and outpatient care, clinical trials and surgical oncology services without having to leave the region. Before City of Hope arrived in Orange County, as many as 20% of local cancer patients left the area to receive advanced cancer care, according to the organization. 
    • “We want every person to have options and access to the most skilled teams, the most cutting-edge treatments and the best research to give them the best chance of survival — this new hospital is part of that journey,” said Robert Stone, CEO of City of Hope.”
  • Per Healthcare Dive,
    • “Cencora is acquiring a majority stake in OneOncology, a support platform for cancer care practices, for $5 billion as the drug distributor ramps up its specialty services offerings.
    • “Cencora already owned a stake in OneOncology, but has signed a definitive agreement to acquire most of the remaining shares from investment firm TPG and other holders for $3.6 billion, and to pay off $1.3 billion of OneOncology’s debt.
    • “OneOncology’s practices will retain a minority interest in the company, according to a release. Cencora expects deal to close by the second fiscal quarter next year.”
  • Beckers Clinical Leadership points out,
    • “Concierge and direct primary care models are rapidly reshaping the U.S. primary care landscape. These membership-based practices, which charge monthly or annual fees for enhanced access and longer visits, have increased in recent years — often operating outside the traditional insurance system.
    • “A research article published in December in Health Affairs by researchers from Baltimore-based Johns Hopkins University, Portland-based Oregon Health & Science University and Boston-based Harvard Medical School found that such practices increased by more than 80% between 2018 and 2023, raising questions about equity, access and the future of the physician workforce.”
  • Lockton issued its 2025 high cost claimant report.
    • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.
    • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.”
    • “What’s changing is not only the magnitude of these claims, but also the instability. Only 21% of high-cost claimants (HCCs) persist year over year, increasing renewal uncertainty and complicating forecasting.”
  • Per an Institute for Clinicial and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. The final report includes key policy recommendations to help ensure fair access.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations “

Monday report

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News informs us,
    • “Approximately 950,000 consumers who currently do not have health insurance coverage through the federally facilitated Health Insurance Marketplace have signed up for a 2026 health plan, the Centers for Medicare & Medicaid Services announced Dec. 5. More than 4.8 million returning consumers have selected 2026 plans. The open enrollment period began Nov. 1 and continues through Jan. 15. Today is the final day for consumers to enroll in coverage that would begin Jan. 1. For those enrolling after Dec. 15, coverage would begin Feb. 1.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 published the Measures Under Consideration List for 2025. These are measures that CMS is considering adopting through the federal rulemaking process for use in Medicare programs. This year’s list comprises 24 unique measures, with some under consideration for multiple CMS programs and others already in use but undergoing substantial change to their specifications. Notably, several measures address topics consistent with the Department of Health and Human Services’ Make America Health Again priority framework, such as chronic illness and nutrition, and all 24 measures rely on data submissions using at least one digital source. In addition, CMS is promoting the early review of five measures that align with the MAHA initiative and are currently in the development stage. 
    • “CMS will convene a consensus-based multidisciplinary group, on which the AHA sits, to provide recommendations to the agency on these measures by Feb. 1. In addition, CMS will seek input through public comments from Dec. 16 through Jan. 6.” 
  • Per a CMS fact sheet,
    • “All seven of CMS’ A/B Medicare Administrative Contractors (MACs) will issue updated Final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers that will be effective January 1, 2026.”
  • Per HHS news releases,
    • “Ralph Abraham, M.D., was sworn in today as Principal Deputy Director of the Centers for Disease Control and Prevention (CDC) by Health and Human Services Secretary Robert F. Kennedy, Jr. He will begin his duties at CDC headquarters in Atlanta on January 5, 2026.
    • “Dr. Abraham has nearly 30 years of experience as a medical practitioner, most recently as Surgeon General of the state of Louisiana. As CDC Principal Deputy Director, he will help realign the agency with its mission as America’s frontline defender against infectious disease.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today convened Lyme disease patients, clinicians, and researchers for a roundtable on diagnostics and clinical needs moderated by HHS Secretary Robert F. Kennedy, Jr. The event fulfills commitments made in the Make America Healthy Again Commission Strategy Report [PDF, 21.85 MB] to address chronic and often unseen illnesses that affect millions of Americans.
    • “For decades, Americans suffering from Lyme disease have been denied the accurate diagnostics and meaningful care they deserve,” said Secretary Kennedy. “Today’s actions push us decisively toward reliable testing and treatment grounded in the real-world experiences of patients. We are committed to delivering the tools that families have waited far too long to receive.”
    • “Participants shared their experiences and recommendations on improving care and advancing research. Senator Susan Collins (R-ME) and Representatives Morgan Griffith (R-VA) and Chris Smith (R-NJ) also engaged in the discussions.
    • “As part of today’s event, HHS announced the renewal of the LymeX Innovation Accelerator with the Steven & Alexandra Cohen Foundation that began during President Trump’s first term. Established in 2020, LymeX is the largest public-private partnership ever built to improve Lyme disease diagnostics and care. The $10 million initiative will advance artificial intelligence tools that support earlier and more accurate detection across stages of infection.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in coordination with the Office of Management and Budget (OMB), the General Services Administration (GSA), the White House Office of Science Technology and Policy (OSTP), and agency leaders across the administration, today announced the establishment of the United States Tech Force (Tech Force)– a new, cross-government program to recruit top technologists to modernize the federal government.” * * *
    • “OPM is proud to announce the initial private sector partners for Tech Force: Adobe, Amazon Web Services, AMD, Anduril, Apple, Box, C3.ai, Coinbase, Databricks, Dell Technologies, Docusign, Google Public Sector, IBM, Meta, Microsoft, Nvidia, OpenAI, Oracle, Palantir, Robinhood, Salesforce, SAP, ServiceNow, Snowflake, Synopsys, Uber, Workday, xAI, and Zoom. OPM welcomes the opportunity to expand this list of partners over time.
    • “In addition, Tech Force is partnering with NobleReach Foundation – a nonpartisan talent platform that brings together America’s best and brightest across industry, academia, and government via initiatives such as its NobleReach Scholars Program – to recruit technologists and support the program.
    • “Read more of what government and tech world leaders have to say about Tech Force here.
    • “For further information, please see OPM’s memo to agencies here. To learn more or apply for Tech Force and for FAQ’s visit TechForce.gov. And follow US Tech Force on X.”  

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device submissions, the agency states it will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission. The FDA similarly intends to consider updating its guidance for drugs and biologics.”
  • and
    • “The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country’s most vulnerable populations –infants and young children. Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.”
  • Fierce Pharma reports,
    • “Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given Milestone Pharmaceuticals its first FDA approval in its 22-year history.
    • “The U.S. regulator has signed off on Cardamyst (etripamil) to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. Cardamyst becomes the first self-administered treatment patients can use to manage their PSVT symptoms.
    • “The calcium channel blocker is a convenient alternative to an emergency room visit, where patients receive an intravenous dose of a drug that “basically reboots your heart,” Milestone CEO Joe Oliveto said in an interview.
  • and
    • “LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga.
    • “The injected treatment, which will carry the commercial name Lerochol, is approved to be used along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
    • “Lerochol arrives on the market with a convenience edge over other PCSK9 drugs, as it is self-administered once monthly and doesn’t need refrigeration because it retains its stability for up to three months at room temperature. By comparison, Amgen’s Repatha and Sanofi and Regeneron’s Praluent are dosed between every two to four weeks, depending on patient needs, and have a shorter shelf life at room temperature.”
  • and
    • “Johnson & Johnson’s Akeega is opening new fronts in prostate cancer treatment with a fresh FDA approval, making it the first precision medicine combo for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
    • “Akeega, a dual-action tablet made up of J&J’s androgen-directed prostate cancer med Zytiga (abiraterone acetate) and the PARP inhibitor niraparib—sold by GSK as Zejula in other indications—is added to corticosteroid medication prednisone to delay disease progression of the aggressive form of prostate cancer.  
    • “J&J’s Amplitude study was the first showing that a PARP inhibitor-androgen receptor pathway inhibitor treatment combination could delay both radiographic and symptomatic disease progression in the disease type, Dana-Farber Cancer Institute’s Bradley McGregor, M.D., noted in a company press release.“
  • and
    • “The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday.
    • “The voucher was granted to J&J for its proposed combination of Tecvayli and Darzalex for previously treated multiple myeloma.
    • “With the voucher, the FDA aims to deliver a decision within one to two months following submission of an application. Normally, FDA drug reviews take up to 10 months, starting from the acceptance of an application.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A new drug has been saturating the fentanyl supply in Philadelphia and moving to other cities throughout the East and Midwestern United States: medetomidine, a powerful veterinary sedative that causes almost instantaneous blackouts and, if not used every few hours, brings on life-threatening withdrawal symptoms.
    • “It has created a new type of drug crisis — one that is occasioned not by overdosing on the drug, but by withdrawing from it.
    • “Since the middle of last year, Philadelphia’s hospitals have been strained by patients coming in with what doctors have identified as medetomidine withdrawal. Although the heart rate slows drastically right after use, in withdrawal the opposite occurs: The heart rate and blood pressure become catastrophically high. Patients experience tremors and unstoppable vomiting. Many require intensive care.”
  • The Wall Street Journal relates,
    • “People susceptible to developing heart issues benefit the most from reducing their consumption of saturated fats, according to a review of research that comes as the federal government prepares to revise dietary recommendations.
    • ‘A paper published Monday in the Annals of Internal Medicine found that people at high risk of developing cardiovascular problems saw a reduction in major health issues including heart attack and stroke when they cut back on saturated fats. The picture was different for people without those same cardiovascular risks. Within five years, cutting saturated fats didn’t yield the same benefits for that group, the review said.”
  • The Washington Post tells us,
    • “Why some people experience long-lasting physical and mental effects from covid-19 could be linked to chronic inflammation, according to new research that experts say could help develop new treatments for the confounding condition that continues to afflict millions.
    • “Some early research on the condition has suggested that long covid’s symptoms linger because the virus persists in people’s bodies. But the new study published Friday in Nature Immunology found that people with long covid had activated immune defenses and heightened inflammatory responses for more than six months after initial infection compared with those who fully recovered.
    • “The latest research “leads to a hypothesis that there might be therapeutic targets related to inflammation that might be worth exploring in clinical studies,” said Dan Barouch, the study’s lead author and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
    • “The study’s findings signal progress in understanding a condition that is estimated to affect more than 400 million individuals around the world as the coronavirus continues to infect people every day, said Ziyad Al-Aly, a clinical epidemiologist at Washington University in St. Louis who studies long covid. There are no drugs approved for treatment of long covid, leaving doctors to tackle individual symptoms with various therapies.”
  • The American Medical Association lets us know “What doctors wish parents knew about fall prevention for kids.
    • “Rabia Nagda, MD, of Texas Children’s Pediatrics, emphasizes that every environment where kids spend time should be built with fall risk in mind.”
  • Per MedPage Today,
    • “Cannabis use in pregnancy is associated with health risks including preeclampsia and low birthweight.
    • “In this secret shopper study, one in five cannabis retailers told callers that cannabis use was safe in pregnancy.
    • “The findings support a need for more public education about the risks of prenatal cannabis use and for guidance to discuss its use with physicians.”
  • Per Health Day,
    • “‘Dual use’ of vaping and smoking might help smokers cut back or quit.
    • “Smokers who also vaped were 4.5 times more likely to quit within a year.
    • “Dual users were also more likely to cut their smoking by half.”
  • and
    • “People could learn within 15 minutes whether they are infected with hepatitis C, thanks to a rapid test developed by Northwestern University.
    • “The test will allow doctors to diagnose infections during an office visit and kickstart patients’ treatment before they leave, researchers said.
    • “This test could revolutionize HCV care in the U.S. and globally by dramatically improving diagnosis, accelerating treatment uptake and enabling more people to be cured faster,” researcher Dr. Claudia Hawkins said in a news release. She’s director of Northwestern’s Institute for Global Health’s Center for Global Communicable and Emerging Infectious Diseases in Chicago.”
  • STAT News reports,
    • “Gene therapy researchers were converging on a holy grail. A few years ago, researchers at labs and companies reported they had engineered viruses that could ferry corrective genes deep into the brain, giving potential entry to a new world of treatments for Alzheimer’s, Parkinson’s, and a slew of rare genetic diseases.
    • “This summer, after years of careful study, the first person underwent gene therapy using one of the new viruses. The patient, a young child, died two and a half days later.
    • “The death has sent concern and uncertainty rippling through labs and companies developing gene therapies for the brain, along with rare disease groups who hoped these tools could deliver long-sought cures. They worry that Capsida Biotherapeutics unearthed a broader risk for other viruses designed to travel like a messenger pigeon to our brains, one that could derail years of progress. 
    • “Capsida has declined to answer questions about the death beyond a brief statement. Its CEO has departed. The information that has leaked out is troubling. The child died of cerebral edema — brain swelling — a clinical course distinct from other deaths tied to gene therapy over the last decade, according to a person familiar with the matter.
    • “Most disturbingly, none of the animal and lab studies Capsida presented indicated such a calamity was possible, making it unclear how other researchers and companies would test for such a risk.” * * *
    • “The best path ahead may be to start new trials in very low doses. But that’s challenging in gene therapy, where patients can only ever receive one dose of a virus in their lifetime, before they develop immunity to it. Still, “we may have to be a bit more conservative,” said Miguel Sena-Esteves, a gene therapy researcher at the UMass Chan Medical School 
    • “Alternatively, companies may have to move forward first in diseases otherwise immediately fatal, where the risk-benefit calculus shifts dramatically. The prion disease that shadows Sonia Vallabh, a researcher at the Broad Institute, is one. 
    • “Whichever way it goes, the gene therapy field has lost the assurance — already tenuous — that tests in animals can predict the toxicities for us. 
    • “In some way,” Vallabh said, “our only safety species is humans.”
  • The Wall Street Journal adds,
    • “Sanofi said its tolebrutinib drug candidate didn’t meet the primary goal in a late-stage clinical trial for multiple sclerosis. It separately said talks with the U.S. Food and Drug Administration had indicated a regulatory review for tolebrutinib in a different form of the disease would take longer than previously expected.
    • “The updates deal a blow to one of the most advanced drugs in Sanofi’s pipeline as the company seeks to move past recent disappointments in clinical trials. Sanofi has turned to dealmaking this year, using funds raised from the sale of a controlling stake in its consumer-healthcare business to replenish its pipeline.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark released its third quarter earnings report on Monday, where its top brass said the insurer expects to see elevated utilization trends persist into 2026.
    • “The Pittsburgh-based organization, which includes Highmark Health Plans and health system Allegheny Health Network, reported a $69 million net loss and a $204 million operating loss alongside $24.6 billion in revenue through the first nine months of 2025. The bulk of that loss came from the health insurance unit, which is continuing to be pressured by care use.
    • “Carl Daley, chief financial officer and treasurer at Highmark Health, told Fierce Healthcare that the company had expected utilization to normalize over the course of the year, and priced plans accordingly. It’s made adjustments in its pricing strategy for 2026 to adapt to the expectation that utilization remains high.”
  • MedTech Dive tells us,
    • “Philips has agreed to acquire SpectraWAVE, a firm making tools to help diagnose and guide treatment of coronary artery disease, the companies announced Monday. They did not disclose the terms of the deal.
    • “SpectraWAVE makes an intravascular imaging system for the coronary arteries. The Bedford, Massachusetts-based company also makes an AI-enabled solution that calculates fractional flow reserve from a single coronary angiogram to support treatment decisions. 
    • “Philips expects the acquisition will expand its portfolio of intravascular imaging and physiological assessment devices. CEO Roy Jakobs said in a statement that the company is “doubling down on image-guided therapy” and expanding its coronary intervention portfolio with the planned purchase.”
  • Cardiovascular Business adds,
    • “Ambulatory surgical centers (ASCs) and office-based labs (OBLs) are poised to play a growing role in cardiovascular care as payment policies shift and health systems look for more efficient ways to manage procedural volume. That trend, and the guardrails needed to ensure patient safety, was the focus of an educational session at TCT 2025 in San Francisco. 
    • “Cardiovascular Business spoke with one of the presenters, Arnold Seto, MD, cath lab director at the Long Beach VA Medical Center, professor of medicine at Charles Drew University, Society for Cardiovascular Angiography and Interventions (SCAI) treasurer and chair of the SCAI Advocacy Committee, to find out more.
    • “Seto said there is wide expectation that lower-acuity interventional cardiology and peripheral procedures will migrate into the ASC environment. This is partly due to better cost effectiveness and the fact that larger centers want to expand into more complex and structural heart procedures without building out their hospital cath labs to be bigger.
    • “The consultants tell us that as many as 25% to 50% of cardiology procedures will be migrating to the ASC environment. The government would prefer that because they pay about two-thirds of the hospital outpatient costs compared with an ASC reimbursement,” he said. He added that the Center of Medicare and Medicaid Services (CMS) is clearly signaling interest in this shift. “We’ve already seen CMS effectively remove all the PCI codes from the inpatient only list, and actually talk about removing everything from the inpatient only list.”
  • Per a Leapfrog news release,
    • “Today, The Leapfrog Group, a national watchdog organization of employers and other purchasers focused on health care safety and quality, announced the 2025 recipients for their elite annual Top Hospital Award and Top Ambulatory Surgery Center (ASC) Award. This national recognition is one of the most competitive honors U.S. hospitals and surgery centers can earn for excellence in patient safety and quality of care. Selected hospitals and ASCs will be celebrated today as part of Leapfrog’s 2025 Annual Meeting and Awards Dinner.” * * *
    • “The award honors hospitals and ASCs that demonstrate the highest performance in the nation on quality and patient safety, including ethical billing and informed patient consent procedures, lower infection rates, prevention of medication errors and surgical safety. To see the full methodology and list of institutions honored as 2025 Top Hospitals, please visit www.leapfroggroup.org/tophospitals. To see the full list of institutions honored as 2025 Top ASCs, please visit www.leapfroggroup.org/ratings-report/top-ascs.” 
  • Genetic Engineering and Biotechnology News points out,
    • “As Eli Lilly (NYSE: LLY) and Novo Nordisk (Nasdaq Copenhagen: NOVO-B) scramble to bring an oral glucagon-like peptide 1 (GLP-1) receptor agonist to market for obesity, a much smaller potential rival spotlighted positive mid-stage clinical data that captivated investors enough to send its share price more than doubling this past week.
    • “Structure Therapeutics (NASDAQ: GPCR) shares soared 102% after it reported positive data from its Phase II ACCESS clinical program assessing its oral GLP-1 candidate aleniglipron in people with obesity and/or overweight with at least one weight-related co-morbidity. Aleniglipron (formerly GSBR-1290) is designed to be a biased G protein-coupled receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway.”
    • “If approved, Structure would compete with oral GLP-1s for weight management by the leading obesity drug developers, whose candidates could both win FDA approval in the new year.”
  • MedCity News notes,
    • “This Year’s Hottest Healthcare Company Isn’t Even a Healthcare Company
    • “Nvidia has quietly become one of the most influential players in healthcare technology by supplying the accelerated computing and AI infrastructure that powers everything from imaging to drug discovery. The company’s restraint — focusing on enabling the ecosystem rather than owning it — has helped cement its role as the indispensable backbone of the healthcare industry’s AI transformation.”

Weekend update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • Roll Call lets us know,
    • “The last week of the congressional session before Christmas could feature a flurry of activity on unfinished business for both the House and Senate, from spending bills and health care costs to nominations.
    • “House Republican leaders released draft legislation Friday afternoon consisting of a package of health proposals aimed at reducing health care costs in 2026, aiming to lay down a marker ahead of the midterm election year as Democrats continue to hammer them over the pending expiration of Affordable Care Act premium tax credits.
    • “The House Rules Committee is scheduled to meet Tuesday afternoon to consider the GOP bill for floor action.” * * *
    • “Senate Majority Leader John Thune, R-S.D., has set up a busy getaway week, having last week filed multiple motions to limit debate on various measures. First on the Senate floor agenda is the final House-Senate agreement on the fiscal 2026 National Defense Authorization Act, with a cloture vote scheduled for 5:30 p.m. Monday.”
    • “Beyond the NDAA, the other percolating legislative business is a much awaited agreement on a second package of fiscal 2026 appropriation bills. The objective remains to pass as many of the regular spending measures as possible before the current continuing appropriations law expires at the end of January. The Senate is scheduled to be out of session the week of Jan. 19. [Here is a link to the 2026 House of Representatives calendar.]
    • “President Donald Trump and Republicans in the Senate are set up for a year-end victory on nominations, again taking advantage of the rules change the Senate GOP enacted earlier this year to allow expedited consideration of bundles of nominations through executive branch resolutions. A package on track for confirmation this week includes 97 nominations for roles across federal departments and agencies, with at least two additional individual nominees also slated for floor action.”
  • Per a House news release,
    • “On Wednesday, December 17, 2025, at 9:00 a.m. ET, the Committee on Oversight and Government Reform will hold a Member Day hearing. The hearing will convene in room HVC 210 of the U.S. Capitol Visitor Center. Members of Congress, regardless of Committee assignment, are invited to testify on issues within the Committee’s jurisdiction, including specific legislation or topics of importance to them, their district, and their constituents.”
  • STAT News reports,
    • “The federal government has sent a record $16 billion to health insurers that sell Medicare drug plans, a flashing red sign that prescription drug spending is blowing up far beyond what government officials and insurance experts had expected.” * * *
    • “Every year, Medicare looks at drug spending data and calculates whether the insurers’ drug plans, known as Part D plans, spent more or less than what they had projected at the start of the year. If insurers’ costs were more than expected, the government gives them an infusion to help subsidize the losses, known as reconciliation payments.
    • “The new $16 billion payout — which was for drug spending in 2024 — was by far the largest reconciliation payment since the Part D program went into effect in 2006, according to Medicare data. It was nearly four times more than the $4.3 billion that Part D plans got in 2023. The closest was $11.1 billion in 2014, when the Affordable Care Act was phasing out the so-called donut hole coverage gap in Part D plans.” * * *
    • “In November, the CBO called for more research into Part D spending “to help explain the unexpected growth in costs.” The group wants to understand if the changes to things like the out-of-pocket cap are driving more people to fill prescriptions if they know their financial exposure is limited.” 
  • MedTech Dive tells us,
    • “The Food and Drug Administration has created a pathway for unauthorized digital health devices to access a new Medicare payment option.
    • “In a policy published last week, the FDA said it will consider waiving typical market access rules for companies that want to join a new Centers for Medicare and Medicaid Services program.
    • ‘The pathway could enable device developers to collect data through real-world use in the CMS’ Advancing Chronic Care with Effective, Scalable Solutions, or ACCESS, program.”
  • Per a National Science Foundation news release,
    • “The U.S. National Science Foundation Directorate for Technology, Innovation and Partnerships (NSF TIP) on Friday announced the launch of a new initiative designed to launch and scale a new generation of independent research organizations. These organizations will focus on technical challenges and bottlenecks that traditional university and industry labs cannot easily solve on their own. NSF seeks feedback on this initiative through a Request for Information (RFI).
    • “As scientific challenges have become more complex and dependent upon the work of cross-disciplinary teams of experts, our nation must expand its scientific funding toolkit to adapt,” said Erwin Gianchandani, NSF TIP Assistant Director. “Tech Labs will provide entrepreneurial teams of proven scientists the freedom and flexibility to pursue breakthrough science at breakneck speed, without needing to frequently stop and apply for additional grant funding with each new idea or development.” * * *
    • “To learn more, read the RFI and plan to join a webinar on Wednesday, Dec. 17, 2025, at 11 a.m. EST. Please register in advance for the webinar.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “Flu hospitalizations are at the third-highest level seen at this point in the season in 15 years, according to the CDC’s latest FluView report [released December 11, 2025].
    • “The cumulative flu hospitalization rate for the week ending Dec. 6 reached 6.9 per 100,000, ranking third highest for week 49 since the 2010–11 flu season. Only the 2022–23 season (36.1) and 2023–24 season (9.5) reported higher rates at this point. Meanwhile, the weekly flu hospitalization rate increased to 2.2 per 100,000, up from 1.7 the week prior.”
  • The New York Times explains what menopause does to a woman’s body from head to toe.
  • MedPage Today adds,
    • “Menopausal hormone therapy (MHT) did not increase breast cancer risk in women with BRCA mutations, according to a study reported here.
    • “In fact, women who used estrogen-only MHT had a significantly lower risk of breast cancer compared with a matched cohort of women who did not use MHT (42.% vs 24.9%). An analysis of different types of estrogen showed either a lower risk of breast cancer or no effect. MHT that included estrogen and progesterone had no effect on breast cancer risk.
    • “The findings added to a growing body of literature showing the safety of MHT, reported Joanne Kotsopoulos, PhD, of Women’s College Hospital and the University of Toronto, at the San Antonio Breast Cancer Symposium. 
  • Medscape tells us,
    • “Semaglutide, a GLP-1 receptor agonist (RA), was associated with a significantly lower risk for adult-onset epilepsy in patients with diabetes than other glucose-lowering drugs (GLDs). Notably, this risk reduction appeared largely independent of improvements in glycemic control or weight.
    • “Approved for type 2 diabetes and obesity management, semaglutide has shown neuroprotective effects in stroke and dementia, but these new findings suggest it may also have a unique neuroprotective mechanism specific to seizure prevention.
    • “If a patient has type two diabetes and a high risk or likelihood of a seizure disorder, it would be beneficial to consider using semaglutide with overall brain health in mind, not just for stroke prevention and cardiovascular health,” Yong Eun, MD, primary care attending, Department of Medicine, NYC Health, Columbia University, New York City, told Medscape Medical News.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare explains “why health plans need to bridge the member trust gap to fully harness technology.”
  • Beckers Payer Issues summarizes “major payer acquisitions have closed or were announced in 2025. 
  • Beckers Hospital Review ranks twenty health systems by operating margins.
    • “As policy uncertainties, reimbursement pressures and continued cuts and closures weigh on hospitals and health systems heading into 2026, third-quarter operating margins showed wide variation. 
    • ‘Several systems, including UnityPoint, Montefiore Health System and Providence, reported operating losses or near-break-even results, while others, such as Allegheny Health Network, UPMC and Northwell Health, recorded only modest gains. On the stronger end, Tenet Healthcare led all systems with a 16.8% operating margin, followed by HCA Healthcare at 12.6% and Universal Health Services at 11.6%.”
  • Per HR Dive, “2026 may mean an extra biweekly pay period. This article explains how HR can prepare. The phenomenon occurs approximately every 11 to 12 years for affected employers, necessitating a 27th pay day.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare, Wellness–

From Washington, DC,

  • The Washington Post reports,
    • “House Republicans unveiled a new health care proposal Friday as they aim to address concerns about rising health insurance costs just weeks before enhanced Affordable Care Act subsidies expire.
    • “The legislation would codify and expand health plans for small businesses, fund reductions of premiums for low-income people in the individual health insurance market and increase transparency in prescription drug pricing, according to House Republican leadership aides.
    • “The proposal would also allow for a separate vote on an extension of the premium ACA tax credits, which subsidize health insurance for most of the 24 million Americans who buy their coverage from the Obamacare Marketplace — the central demand Democrats and moderate Republicans have made in the recent health care debate.
    • “The House is expected to vote on the proposal next week before leaving Washington for a two-week holiday break. If passed, it is unclear if the proposal could succeed in the Senate, where it would require 60 votes to overcome a filibuster.”
  • FEHBlog observation — This week, the Democrat leadship in the Senate offered a three year extension extension of the Biden subsidies while the Republican leadership offered a new approach with no transistion period. Both offerings were doomed to fail. The FEHBlog hopes that cooler heads prevail over the next week.
  • Govexec relates,
    • “The House voted 231-195 on Thursday to pass legislation that would nullify President Trump’s efforts to strip more than 1 million federal workers of their collective bargaining rights, sending the measure over to the Senate, where its prospects are less rosy.
    • “Twenty Republican lawmakers broke ranks to support the Protect America’s Workforce Act (H.R. 2550) on the floor. Introduced by Reps. Jared Golden, D-Maine, and Brian Fitzpatrick, R-Pa., the measure effectively nullifies Trump’s March executive order barring unions at more than 40 federal agencies under the guise of national security and bars federal agencies from terminating any union contracts that were in place prior to the edict’s signature.”
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Dec. 11 announced the launch of the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence Model, a voluntary payment model that will fund up to 30 chronic disease prevention and health promotion proposals. The proposals must include evidence-based functional or lifestyle medicine interventions not covered by Original Medicare. Under the MAHA ELEVATE Model, CMS said it will evaluate necessary data on the cost and quality of such interventions to inform future decisions on the feasibility of including them in Original Medicare. The agency will release a funding notice in early 2026 for the first cohort, which will begin Sept. 1, 2026. The second cohort will begin one year later.”
  • The U.S. Office of Personnel Management announced today that it is seeking public comments on its plan to resurrect its FEHB and now also PSHB health claims data warehouse.
    • “OPM is collecting service use and cost data from FEHB and PSHB Carriers, including medical claims, pharmacy claims, encounter data, and provider data. This data will enable OPM to oversee health benefits programs and ensure they provide competitive, quality, and affordable plans. OPM requires Carriers to report necessary information and permit audits and examinations to manage the FEHB Program effectively. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered entities, including carriers, to disclose protected health information (PHI), including service use and cost data, to health oversight agencies, such as OPM, for oversight activities authorized under 45 CFR 165.512(d)(1).”
    • This is a legally flawed analysis. The FEHB Act, 5 U.S.C. Sec. 8910(b), states
      • “(b) Each contract entered into under section 8902 of this title shall contain provisions requiring carriers to—
      • “(1) furnish such reasonable reports as the Office determines to be necessary to enable it to carry out its functions under this chapter; and
      • “(2) permit the Office and representatives of the Government Accountability Office to examine records of the carriers as may be necessary to carry out the purposes of this chapter.”
    • Furnishing all claims data to OPM is a not a reasonable report in any sense of the English language, and the HIPAA Privacy Rule does not give health oversight agencies new data access rights. See Fed. Reg. 82,462, 82,528 (Dec. 28, 2000). OPM should head back to the drawing board for consultations with carriers.
    • The public comment deadline is February 10, 2026.
  • On a related note, per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is pleased to announce the 2026 CMS Burden Reduction Conference taking place February 25, 2026, from 9:00 a.m. to 1:00 p.m. ET. This year’s conference will be a hybrid event, with in-person programming at the Hubert H. Humphrey (HHH) Building in Washington, DC, and a fully supported virtual option for remote attendees. In-person attendance will be limited due to space.”
  • OPM should hold a similar event for overburdened FEHB and PSHB carriers.

From the Food and Drug Adminstration front,

  • Per Fierce Pharma,
    • “Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new indication for its monoclonal antibody Uplizna.
    • “Thursday, the FDA greenlighted Uplizna (inebilizumab) to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. After two loading doses, Uplizna for gMG is administered just twice a year, Amgen noted in a Dec. 11 press release.”
  • and
    • “After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection (STI), which affects more than 80 million people around the world each year. 
    • “On Friday, the U.S. regulator green lit Innoviva’s Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea. The nod comes less than 24 hours after the agency granted an approval in the same indication to GSK’s Blujepa, which was already on the market for uncomplicated urinary tract infections following its approval in March.
    • “The endorsements are similar in that both therapies are indicated for those ages 12 and older where standard of care treatment is contraindicated or where patients are intolerant or unwilling to use the first line of treatment.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to the enVast mechanical thrombectomy system from Texas-based Vesalio.
    • “The company said the system offers a new approach to clot capture and the removal of large thrombus burden (LTB) in patients undergoing primary percutaneous coronary intervention (PCI). Thrombectomy is used in the coronary arteries to quickly remove clots to restore blood flow following a heart attack to minimizing myocardial damage.
    • “With FDA clearance and the upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy,” Steve Rybka, CEO of Vesalio, said in a statement. “Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase in most areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing emergency department or urgent care visits for children ages 9 months to 4 years. It was 56% effective for those ages 5-17 years old. “These findings suggest that vaccination with a 2024–2025 COVID-19 vaccine dose provided children with additional protection against COVID-19–associated ED/UC encounters compared with no 2024–2025 dose,” the CDC wrote.”
  • The New York Times reports,
    • “To treat their pain, anxiety and sleep problems, millions of Americans turn to cannabis, which is now legal in 40 states for medical use. But a new review of 15 years of research concludes that the evidence of its benefits is often weak or inconclusive, and that nearly 30 percent of medical cannabis patients meet criteria for cannabis use disorder.
    • “The evidence does not support the use of cannabis or cannabinoids at this point for most of the indications that folks are using it for,” said Dr. Michael Hsu, an addiction psychiatrist and clinical instructor at the University of California, Los Angeles, and the lead author of the review, which was published last month in the medical journal JAMA. (Cannabis refers to the entire plant; cannabinoids are its many compounds.)”
  • The AP informs us,
    • “The U.S. suicide rate dropped slightly last year from some of the highest levels ever reported, preliminary data suggests. Experts say it’s hard to know exactly why, or whether the decline will continue.
    • “A little over 48,800 suicide deaths were reported in 2024, according to provisional data from the Centers for Disease Control and Prevention, roughly 500 fewer than the year before.
    • “The overall suicide rate fell to 13.7 per 100,000 people.”
  • The Washington Post relates,
    • “Solving a technical challenge that has stymied science for 40 years, researchers have built a robot with an onboard computer, sensors and a motor, the whole assembly less than 1 millimeter in size — smaller than a grain of salt.
    • “The feat, accomplished by a partnership of researchers at the University of Pennsylvania and University of Michigan, advances medicine toward a future that might see tiny robots sent into the human body to rewire damaged nerves, deliver medicines to precise areas, and determine the health of a patient’s cells without surgery.”
  • Per Healio,
    • “GLP-1 receptor agonists are not associated with increased risks for dry age-related macular degeneration or cataract development, according to two recently published studies.
    • “The data instead showed significantly reduced risk for cataracts, as well as lower risk for dry AMD, linked with the use of GLP-1s, according to Abhimanyu Ahuja, MD, an ophthalmology resident at the Oregon Health & Science University Casey Eye Institute, and colleagues.
    • “Other studies have demonstrated that these medications have anti-inflammatory and neuroprotective properties,” Ahuja told Healio. “We wondered whether they might influence the risk of conditions like macular degeneration or cataracts in older adults.”
  • Per MedTech Dive,
    • “AtriCure, whose devices are used to treat atrial fibrillation and related conditions, said Thursday the first procedures were performed in patients with its new dual energy platform.
    • “The system integrates pulsed field ablation with a radiofrequency ablation approach using the company’s cardiac clamp technology. Surgeons can use either method independently or in combination.
    • “The platform is not yet approved for use in any market. AtriCure said it expects to initiate a clinical trial in the coming year.”
  • Per Biopharma Dive,
    • “Arcus Biosciences will terminate work on a TIGIT-targeting cancer drug following a decision to cancel a Phase 3 trial because it didn’t appear likely to improve patients’ survival, the company said in a statement Friday.
    • “Called domvanalimab, the drug was being tested in combination with the immunotherapy zimberelimab and chemotherapy against Bristol Myers Squibb’s Opdivo and chemo in gastric and esophageal cancers that haven’t been treated before. Arcus said an independent data committee recommended ending the trial because the domvanalimab combination wasn’t likely to help patients live longer.
    • “The domvanalimab-based combination was the centerpiece of a partnership with Gilead Sciences that led the bigger company to buy a 33% stake in Arcus and pay $900 million just to secure rights.”

From the U.S. healthcare business and artificial intelligence front,

  • Healthcare Dive reports,
    • “Hospitals are managing series of cost, workforce and reimbursement challenges as they navigate uncertainty at the close of 2025 and beyond, according to a new report from Kaufman Hall.
    • “Health systems are attempting to mitigate the impact of tariffs and increasingly expensive supplies, according to Kaufman Hall’s 2025 Health System Performance Outlook report. At the same time, hospitals are trying to retain clinical staff and outsource other functions, according to the report.
    • “Only 30% of hospital leaders surveyed expect balance sheets to improve in 2026, while 30% expect them to lower and 40% projected little change. The split highlights how uncertain health systems feel about the future, especially from recent regulatory changes in the “Big Beautiful Bill” and the likely expiration of Affordable Care Act subsidies.”
  • Beckers Hospital Review relates,
    • “Dallas-based Tenet Healthcare reached a record high stock price of $218 on Nov. 25, capping off a transformative year that highlights investor confidence in the system’s ongoing shift toward specialty and outpatient care.
    • “As of Dec. 12, Tenet stock remained elevated at $199, up nearly 60% from $125 on Jan. 2. The spike reflects investor optimism around Tenet’s long-term strategy to transform into a value-based care enterprise anchored by its ambulatory business, United Surgical Partners International.
    • “In 2024, Tenet sold 14 hospitals for a combined $4.8 billion as part of a sweeping overhaul. The system now operates 50 acute-care hospitals while aggressively expanding its ambulatory surgery center footprint through USPI.”
  • Beckers Payer Issues tells us about 14 payer AI moves this year and “Turquoise Health has detailed its first comprehensive payer price transparency scores in its 2025 impact report, evaluating machine-readable file quality across 97 payers.” 

Thursday report

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “A Democratic effort to extend expiring healthcare subsidies drew some Republican votes but failed to advance in the Senate on Thursday, leaving no clear path in Congress for aiding millions of Americans facing soaring costs for their Affordable Care Act coverage next year.
    • “The proposal would have extended the enhanced Covid-era ACA subsidies for three years. The bill was backed by 51 senators—including Republican Sens. Lisa Murkowski and Dan Sullivan of Alaska, Susan Collins of Maine and Josh Hawley of Missouri—with 48 opposed, short of the 60 votes needed to advance under the Senate’s filibuster rule.
    • “Republicans, who control the chamber 53-47, put forward an alternative healthcare bill that wouldn’t extend the subsidies but instead offers federal funds to some households to put toward out-of-pocket healthcare costs. That proposal failed with 51 in favor and 48 opposed. All Republicans except Sen. Rand Paul of Kentucky supported the measure, while no Democrat voted for it.
    • “The lack of progress in Congress has left many of the nation’s ACA enrollees in a precarious situation. With open enrollment closing on Dec. 15 for plans starting Jan. 1, households are signing up now for coverage with sharply higher costs, with no guarantee that Congress will act to restore subsidies and bring the price tag down. Others are expected to skip coverage altogether.
    • “With the failure of the two votes Thursday, hope is fading for any deal to extend the subsidies before the end of the year, if at all. The next major legislative deadline is Jan. 30, when lawmakers need to pass a new bill funding the government. Still, some lawmakers believed a deal could still be reached.
    • “I hope that there are enough people on both sides who want to come to the table and get a compromise,” said Sen. Jeanne Shaheen (D., N.H.).”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “OPM’s retirement application pile remains large as the year draws to a close
    • “New retirees awaiting full benefits may face holiday heartache as the backlog swelled to nearly 50,000 by the end of November.”

From the Food and Drug Administration front.

  • The Washington Post reports,
    • “An in-home headset that allows people with depression to send mild electrical current to their brains has been cleared by the Food and Drug Administration, in what medical experts consider a milestone for expanding mental health treatment beyond drugs.
    • “The prescription device, made by Flow Neuroscience, is designed to counteract moderate to severe depression in adults by delivering electric stimulation to an area of the brain that controls mood and stress. While such stimulation is widely used to treat depression, Flow is aiming to fill a niche with a product that delivers a relatively low dose of current at home, instead of at specialized clinics. The FDA said testing showed “modest” results for patients.”
  • Per MedTech Dive,
    • “Intuitive Surgical said Wednesday its da Vinci SP surgical robot received Food and Drug Administration clearance for use in inguinal hernia repair, gallbladder removal and appendectomy procedures.
    • “The clearances add to the single port robot’s indications in urology, colorectal, thoracic and transoral procedures, as Intuitive works to expand adoption of the platform, launched in the U.S. in 2018.
    • “The SP system, for surgery through a single incision or natural orifice, is designed to help surgeons access narrow or deep spaces within the body to perform more complex procedures. The surgeon can control up to three multi-jointed instruments and a 3D-HD imaging endoscope through the entry point.”
  • Fierce Pharma relates,
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • “The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • “Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.
    • ‘At the core of the guidance is a call for all promotional materials to be “accurate, truthful, and non-misleading.”
  • STAT News tells us,
    • “Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, the Food and Drugs Administration hosted an expert panel to discuss the other sexual hormone with a potentially outdated black box: testosterone. 
    • “Nine experts, including academics, clinicians, and the CEO of a pharmaceutical startup focused on testosterone products, delivered lectures and answered questions highlighting the importance of testosterone as a marker of broader male health. They also promoted increased engagement with its therapeutic value and recommended changes in labeling and substance control.” 
  • Beckers Hospital Review shares background about and FDA review process.
    • “The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency has not formally issued draft guidance, recent public comments, advisory committee discussions and internal policy memos outline a framework that is intended to streamline clinical trials, tighten manufacturing oversight and modernize postmarket safety monitoring.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “South Carolina’s measles outbreak is “accelerating” in the wake of Thanksgiving travel and a lack of vaccinations, an epidemiologist for the state’s Department of Public Health (DPH) warned Wednesday, after authorities traced a sizable outbreak to a church in the state’s northwest.
    • “Of the 111 measles cases recorded in that area, known as the Upstate region, 105 involved people who were unvaccinated while three involved those who were partially vaccinated, state epidemiologist Linda Bell said at a news briefing. One dose of the vaccine is 93 percent effective against measles, while the full two-dose regimen is 97 percent effective, according to the Centers for Disease Control and Prevention.
    • “At least 254 people had been placed in quarantine as of Tuesday, 16 of whom are in isolation, the DPH said in a news release.
    • “Bell said that 27 new cases had been reported since Friday, bringing the total reported to the DPH this year to 114. “Accelerating is an accurate term. That is a spike in cases we are concerned about,” she said in response to a question from a reporter, adding that South Carolina has “lower than hoped for” vaccination coverage.”
  • NBC News tells us,
    • “Heart disease has long been the top killer of women in the United States, but new research suggests uterine fibroids, which many may not even be aware they have, could be putting them at a significantly greater risk.
    • “A large, 10-year study found that women with leiomyomas had an 81% higher long-term risk of heart disease than those without the common condition. Women with fibroids — generally benign tumors that can form on or in the uterus — also had higher individual risks of cerebrovascular, coronary artery and peripheral artery diseases a decade after diagnosis.
    • “The study involved more than 2.7 million U.S. women and was led by scientists at the University of Pennsylvania Perelman School of Medicine. It was published Wednesday in the Journal of the American Heart Association.
    • “We do hope that our study adds to this growing evidence that reproductive health may provide important insights into cardiovascular health,” said lead author Julia DiTosto, a doctoral candidate in epidemiology at Penn. “There is a need for more information on how exactly, biologically, these conditions are related and also identifying potential strategies for cardiovascular prevention.”
  • Per Healio,
    • “Younger age at diagnosis did not appear to affect outcomes among women with breast cancer who harbor BRCA mutations, according to study results presented at San Antonio Breast Cancer Symposium.
    • “In addition, survival did not differ between very young women — defined as 30 years or younger — and those aged 31 to 40 years.
    • “Age per se should not be considered a negative prognostic factor in BRCA carriers when appropriate treatment is provided,” Matteo Lambertini, MD, PhD, associate professor of medical oncology and consultant in medical oncology at University of Genova-IRCCS Policlinico San Martino Hospital in Italy, said during a presentation.”
  • Per Radiology Business,
    • “Targeting women who are eligible for both lung and breast cancer screening pays off, according to new research.  
    • “Numerous studies have explored poor LCS adherence, a problem less pronounced in screening mammography. One previous study estimated about 58% of LCS-eligible women reported having a mammogram over the past two years versus just 8% who underwent low-dose CT for lung cancer. 
    • “This presents a potential opportunity, experts detailed Dec. 1 in the Journal of the American College of Radiology. Researchers at two academic medical centers recently aimed to leverage mammography adherence to bolster LCS uptake and are finding success, with a significant uptick in total LDCT examinations. 
    • “It has been more than 10 years since annual screening for lung cancer was recommended, and screening rates still are disappointingly low. There are many reasons for these low rates, but mostly identifying eligible individuals is challenging in the primary care setting, and there is evidence showing a surprising lack of awareness about lung cancer screening among eligible individuals,” study co-investigator Robert Smith, PhD, with the American Cancer Society, which funded the analysis, said in a statement. “There is enormous potential here, and the ACS is thrilled with the outcome of this study.” 
  • Medscape discusses the rising number of double diabetes cases and “What Doctors Should Know About Viral Sleep Trends.”
  • Per Health Day,
    • “Many young Americans are still smoking nicotine, tobacco or cannabis, even as edibles and vapes continue to grow in popularity.
    • “A University of Michigan study looked at how 12- to 34-year-olds are using these substances today. Researchers examined data from 8,722 individuals who had used at least one of these products within the last 30 days.
    • “On average, users tried about two products during that time, and researchers identified six main patterns of use:
      • “Combustible tobacco: 31%
      • “Multiple forms of cannabis: 27%
      • “Vaping nicotine: 18%
      • “Using multiple forms of nicotine, tobacco and cannabis: 14%
      • “Cannabis edibles only: 5%
      • “Multiple forms of nicotine and tobacco: 5%
    • “The largest group, and still the most concerning, were people who smoked tobacco, researchers said.”
  • BioPharma Dive relates,
    • “An experimental Eli Lilly obesity medicine helped patients lose more than a quarter of their body weight while offering relief from knee osteoarthritis in a Phase 3 study released Wednesday.
    • “Patients on the highest dose of retatrutide lost an average of 28.7% of their body weight after 68 weeks of treatment, compared with 26.4% on the lower dose and 2.1% on placebo, Lilly said. Additionally, 39% of patients on the highest dose achieved weight loss of 30% or more and 24% of those on that dose saw their weight drop by 35% or more, Lilly said.
    • “Lilly has now produced a drug with the best weight loss results of any medication to date, Leerink Partners analyst David Risinger wrote in a note to clients. Before the release, Risinger said he was looking for weight loss in the mid-high 20% range, which would surpass the effects seen with Lilly’s tirzepatide, the world’s best-selling drug, sold as Zepbound for obesity.”
  • Per Genetic Engineering and Biotechnology News,
    • “In 2022, monkeypox virus (mpox) caused more than 150,000 cases—causing flu-like symptoms and painful rashes and lesions. The outbreak resulted in almost 500 deaths. At the time, vaccines developed to fight smallpox were repurposed to help the most vulnerable patients. But that vaccine—manufactured from a whole, weakened virus—is complicated and costly to make.
    • “Now, a major inroad towards a new and more effective way to fight monkeypox virus has been published. A team used the AlphaFold 3 model to identify a viral surface protein—OPG153—as a good target for developing new antibody therapies to treat mpox or for use in a vaccine. When mice were injected with the viral surface protein, the animals produced antibodies that neutralized the monkeypox virus, suggesting the breakthrough could be used in a new mpox vaccine or antibody therapy.
    • “This work is published in Science Translational Medicine in the paper, “Antigen-agnostic identification of poxvirus broadly neutralizing antibodies targeting OPG153.”
    • “Unlike a whole-virus vaccine that’s big and complicated to produce, our innovation is just a single protein that’s easy to make,” said Jason McLellan, PhD, professor of molecular biosciences at The University of Texas at Austin.”
  • and
    • “Findings from a new study led by scientists at Stanford University School of Medicine and their colleagues elsewhere show that a single signaling pathway controls whether immune cells attack or befriend cells that they encounter in the body. By manipulating this pathway, scientists may be able to tweak the immune response to treat a range of diseases, including cancers, autoimmune disorders, and more. Full details are provided in a new Nature paper titled “Erythropoietin receptor on cDC1s dictates immune tolerance.”  
    • “The findings build on work published in an earlier study by the same research group that described a role for erythropoietin (EPO) in the immune system—specifically, controlling how dendritic cells respond to real or perceived threats. The current study, which was performed in mice, helps to illuminate an aspect of peripheral immune tolerance, which is responsible for preventing inappropriate attacks on healthy tissue. The scientists who discovered regulatory T cells (Tregs), which are the key cellular players in peripheral immune tolerance, were awarded the 2025 Nobel Prize in physiology or medicine.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark and Blue Cross and Blue Shield Kansas City have announced plans to affiliate.
    • “The insurers revealed on Thursday that they will enter into an affiliation where Blue Cross KC will maintain its local brand and operations, but will be able to tap into Highmark’s resources to accelerate innovation for its members. Highmark is the fifth-largest Blues plan in the U.S.
    • “Through the affiliation, Blue Cross KC’s financial reserves and earnings will remain within its organization, and Highmark will support its evolution through administrative capabilities, technology and new tools to enable the insurer to build new products and operational efficiencies.
    • “Erin Stucky, CEO of Blue Cross KC, said in the announcement that after a “comprehensive” process to find a partner, the team is “confident” that Highmark was the right choice to “help us deliver greater value for our community.”
  • and
    • “Connecticut’s Office of Health Strategy (OHS) approved on Wednesday Hartford HealthCare’s Emergency Certificate of Need application to acquire two hospitals and related assets from the bankrupt Prospect Medical Holdings. 
    • “The expedited decision ensures continuity of care for Eastern Connecticut residents, while imposing specific conditions designed to ensure preservation of healthcare access and quality and control cost growth,” Amy Porter, the state regulator’s acting commissioner, said in an announcement. “The OHS staff conducted a rigorous and highly efficient process made possible by the emergency [certificate of need] statute.”
    • “Hartford HealthCare’s $86.1 million bid was the only one received for Manchester Memorial and Rockville General, and had previously been accepted by Prospect and green lit by a bankruptcy judge. The facilities had been at the heart of a now-settled legal dispute between bankrupt Prospect Medical Holdings and Yale New Haven Health, which prior to the bankruptcy had offered hundreds of millions more for the locations.”
  • and
    • “Aradigm Health, a new benefits platform aimed at easing the financial sting of coverage for cell and gene therapies, has launched out of stealth.
    • “The company is making its debut backed by a $20 million series A funding round that it intends to use to further enhance platform development, building out its team and growing its partnerships with payers and providers. The round was led by Frist Cressey Ventures with backing from Andreessen Horowitz and Morgan Health.
    • “Andreessen Horowitz led the company’s $5 million seed round in 2024 as well, according to an announcement.”
  • Healthcare Dive tells us,
    • “Elevance has added a former Pfizer executive to its board, the latest addition of pharmaceutical industry veteran as the insurer focuses on building its pharmacy services.
    • “Amy Schulman will start as an independent director of Elevance effective Jan. 12, the insurer announced Wednesday. Schulman will serve on the board’s audit and finance committees.
    • “Schulman’s “insight into the intersection of science, technology, and patient care makes her an exceptional addition as we continue to advance and expand our services,” Ramey Peru, chair of Elevance’s board, said in a statement.”
  • Beckers Hospital Review reports,
    • “Austin, Texas-based UT Health Austin intends to go live with a new inpatient Epic EHR on the same day it opens its new multibillion-dollar academic medical center.
    • “With the net-new implementation, the health system will be able to easily adopt many of the vendor’s latest AI and automation features.
    • “It is a really unique opportunity to build this from scratch, from the ground up,” UT Health Austin CIO Michael Ryan told Becker’s. “We’re really taking a fresh-eyes look at it. … We don’t have many existing legacy processes or legacy ways of working.”
    • “The $2.5 billion University of Texas at Austin Medical Center, slated to break ground in 2026, will include a new UT hospital and MD Anderson Cancer Center. Austin is currently the largest American city without an academic medical center.”
  • and
    • “U.S. News & World Report released its 2026 Best Hospitals for Maternity Care ratings Dec. 9, which also recognize hospitals providing services to underserved communities.
    • “The media company used self-reported maternity care data to identify 147 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack adequate access to such care.:”
    • The article lists all 147 identified hospitals by State.
  • and
    • “Many health systems are expanding their participation in value-based care models over the next few years, though few have substantial revenue at risk in value-based contract arrangements, according to a new Sage Growth Partners report. 
    • “The report, published Dec. 11, is based on a survey of 101 hospital and health system C-suite leaders from academic medical centers, integrated delivery networks and independent hospitals.’
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation. Our primary comparison was with the smoking cessation drug varenicline.
    • “Smoking cigarettes is the number one cause of preventable deaths in the US, and so any new therapy to assist with smoking cessation is extremely important,” said ICER’s Chief Medical Officer, David Rind, MD. “The drug we reviewed for this assessment, cytisinicline, is the same molecule as cytisine, a drug long used for smoking cessation in Eastern Europe. Our analyses show that cytisine/cytisinicline has similar efficacy but significantly fewer gastrointestinal side effects than varenicline, a common prescription drug used for smoking cessation in the US. We heard from experts that they are hopeful cytisinicline will be priced so as to be widely available to those who need it.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), on January 15, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Per MedTech Dive,
    • “Natera last week said it completed the acquisition of Foresight Diagnostics, expanding the company’s position in solid tumor molecular residual disease detection, particularly in lymphoma, a cancer of the lymphatic system.
    • “The all-stock transaction was valued at $275 million upfront, plus up to $175 million in revenue- and reimbursement-based milestone payments.
    • “Foresight’s PhasED-Seq technology will be integrated into Natera’s Signatera platform to further differentiate performance in solid tumors.”

Midweek update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, Medicare, OPM, Patient safety, SDOH, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Senate plans two healthcare votes Thursday: one on a GOP bill that would put as much as $1,500 a year into health savings accounts in lieu of providing subsidies to cover premiums, and the second on a Democratic plan that extends ACA subsidies for three years. Neither is expected to reach the 60 votes needed to advance, but the willingness of some Republicans to consider any form of ACA extensions has opened the door to possible talks if the partisan measures fail.
    • “In the House, Speaker Mike Johnson (R., La.) said Republicans plan to put on the floor next week a package of healthcare proposals that doesn’t include extending subsidies. But other lawmakers see an ACA extension as the only way to prevent widespread pain ahead of the 2026 midterms and get a GOP-led Congress in position to make more sweeping changes.
    • “Rep. Jim Jordan (R., Ohio)—a onetime leader of the hard-line House Freedom Caucus—argued in a closed-door House Republican meeting that the party needed its own plan to temporarily extend the subsidies in tandem with more sweeping changes. If they didn’t, he warned, conservatives could be sidelined by centrists’ push to bring their own ACA extension to the floor.
    • “There’s a whole list of good things that we need to put in the legislation,” Jordan said in an interview. “But we also need to recognize reality, which is the cliff is coming in 21 days, and we have members who are very concerned about that. I think we all are.”
  • The Hill adds,
    • “The House on Wednesday easily passed the annual defense policy bill, sending the mammoth, $900 billion measure to the Senate ahead of the year-end deadline.
    • “The measure, known as the National Defense Authorization Act (NDAA), passed the lower chamber by a vote of 312-112. Ninety-four Democrats and 18 Republicans opposed the bill.
    • “The NDAA, a traditionally bipartisan bill that lays out defense priorities for the next year, would increase pay for service members, provide some military aid to Ukraine, restrict U.S. investment in China and fully repeal sanctions on Syria, among other things.”
  • Axios points out,
    • “Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.” * * *
    • “A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • “The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • “Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.” * * *
    • “Federal budget analysts previously used the Consumer Price Index as a proxy for lab payments. That measurement showed that delaying the changes appeared to save Medicare money. 
    • But the analysts have changed their model and now estimate that delaying the payment cuts will add to Medicare costs.”
  • Govexec tells us,
    • “The heads of the Office of Management and Budget and the Office of Personnel Management unveiled plans Wednesday to build a single information technology platform to manage all human capital data across the federal government. 
    • “In a joint memo, OMB Director Russ Vought and OPM Director Scott Kupor described a two-year plan to transition the federal government’s collection of disparate human resources networks onto a single system dubbed Federal HR 2.0.
    • “For too long, the Federal Government has lacked what is taken for granted at any other organization — a single system of record for personnel management. Instead, the Federal Government spends an inordinate amount each year on numerous costly, duplicative, and outdated core human capital management (“Core HCM”) systems,” the memo said. 
    • “As part of the plan, the memo said OMB and OPM officials will lead efforts “to procure a modern, best-in-class commercial Core HCM system” for governmentwide adoption by fiscal 2028.”
  • The Journal of Accountancy informs us,
    • “The IRS provided guidance Tuesday on new tax benefits for health savings accounts (HSAs) that include allowing bronze and catastrophic plans to be considered HSA-compatible under Sec. 223.
    • “The changes, which were part of H.R. 1, P.L. 119-21, commonly known as the One Big Beautiful Bill Act, generally expand the availability of HSAs under Sec. 223 and were outlined in Notice 2026-05.” * * *
    • “The IRS guidance also covered:
      • “Telehealth and remote care services: H.R. 1 made permanent the ability to receive telehealth and other remote care services before meeting the HDHP deductible while remaining eligible to contribute to an HSA, effective for plan years beginning on or after Jan. 1, 2025.
      • “Direct primary care (DPC) service arrangements: Beginning Jan. 1, 2026, an otherwise eligible individual enrolled in certain DPC service arrangements may contribute to an HSA. In addition, they may use their HSA funds tax-free to pay periodic DPC fees.”
    • “The IRS is seeking comments on Notice 2026-05 by March 6, 2026.”
  • Per Fierce Pharma,
    • “For more than two years, the U.S. Federal Trade Commission has been taking certain drugmakers to task over their alleged listing of “improper” patents in an FDA registry, a practice the agency says thwarts generic competition. 
    • “Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
    • “Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes, chronic obstructive pulmonary disease and for epinephrine autoinjectors, the FTC said. The removals from the FDA’s Orange Book registry will “pave the way for greater competition for generic alternatives” to more than 30 products, the agency explained.” * * *
    • “The AHA Board of Trustees has engaged WittKieffer to conduct a national search for Pollack’s successor as part of a planned transition. Pollack will remain fully engaged until the transition is complete.
    • “Recognizing Pollack’s commitment to the association, the AHA Board last month voted to bestow on him the title of AHA President and CEO Emeritus for when the transition is complete.”
  • The American Medical Association announced,
    • “AHA President and CEO Rick Pollack today announced his plans to retire by the end of 2026. A 43-year veteran of the association, Pollack has served as its chief executive for the past decade.
    • “Under Pollack’s leadership, the AHA steered hospitals through the COVID-19 pandemic, securing critical resources and regulatory flexibility to keep hospitals and health systems open and caring for patients during the most challenging public health crisis of recent time. Pollack launched bold initiatives to strengthen the health care workforce, advance quality and patient safety, and fortify cybersecurity defenses through partnerships with the FBI and other government agencies.
  • Per a Department of Justice news release,
    • “United States Attorney David Metcalf announced today that Recovery Centers of America (RCA) has agreed to pay $1,000,000 to resolve allegations that it failed to comply with provisions of the Controlled Substances Act (CSA) that are designed to prevent the diversion of controlled substances for illegal uses, and an additional $1,000,000 to resolve allegations that it violated the False Claims Act (FCA) by billing the government for drug and alcohol treatment services that it failed to adequately provide.
    • “The United States’ allegations under the CSA arise from audits and investigations the Drug Enforcement Administration (DEA) conducted at RCA facilities in Pennsylvania and Maryland between 2019 and 2024. Based on those audits and investigations, the United States contends that RCA dispensed controlled substances in an unlawful manner, that certain controlled substances were missing from the company’s records, and that the company failed to comply with additional recordkeeping requirements of the CSA.
    • “In addition, the United States alleges that, at certain facilities during a period from 2017 through 2019, RCA violated the FCA by billing the Federal Employees Health Benefits Program and Medicaid for the care of beneficiaries to whom it failed to provide and document the requisite treatment services.” * * *
    • “The resolution obtained in this matter was the result of a coordinated effort among the United States Attorney’s Office for the Eastern District of Pennsylvania, the DEA, the Office of Personnel Management Office of Inspector General, and the Department of Health and Human Services Office of Inspector General.
    • “The matter was handled in the U.S. Attorney’s Office for the Eastern District of Pennsylvania by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer and former auditor Dawn Wiggins.
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
    • “GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
    • “FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.”
  • Fierce Pharma adds
    • “The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione Telethon the first nonprofit to usher a gene therapy across the regulatory finish line in the U.S.
    • “Branded as Waskyra, the drug is specifically indicated for children 6 months and older, as well as adults who have a mutation in the WAS gene. To be eligible for the ex vivo gene therapy, patients must have no available human leukocyte antigen-matched related stem cell donor and be cleared for hematopoietic stem cell transplantation, the FDA said in its Dec. 9 announcement.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., said in a release.”
  • and
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.”
  • Per Beckers Health IT,
    • “The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials.
    • “The cloud-based tool, AI-Based Histologic Measurement of NASH (AIM-NASH), is designed to assist pathologists in assessing liver biopsy images, according to a Dec. 8 news release. It evaluates disease activity by scoring steatosis, hepatocellular ballooning, lobular inflammation and fibrosis according to the NASH Clinical Research Network scoring system.
    • “AIM-NASH uses AI to analyze digital images of liver tissue, but human pathologists remain responsible for interpreting the results. They review the entire slide and AIM-NASH output before accepting or rejecting the scores.”
  • BioPharma Dive notes,
    • “Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the time before a type of event occurs, in randomized, controlled trials. The control groups in those studies must also take into account the existing standard treatments, including other approved CAR-T therapies, and prove superior unless “adequately justified and discussed” with the FDA. The new protocol represents a higher approval bar for CAR-T therapies, which, historically, have been cleared based on their ability to induce responses in single-arm studies.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today said the United States has 1,912 confirmed measles cases so far in 2025, an increase of 84 cases since last week and a bad sign as holiday gatherings, travel, and indoor activities is set to pick up in the final weeks of the year. 
    • “In January 2026, the United States is at risk of losing its measles elimination status because of ongoing transmission chains from a West Texas outbreak that began early last year and sickened roughly 800 people. The country first gained elimination status in 2000. 
    • “Eighty-eight percent of cases in the United States this year are outbreak-associated, and there have been 47 outbreaks recorded. Last year, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.
    • “Currently Utah, Arizona, and South Carolina are seeing large outbreaks that since Thanksgiving have pushed state totals well past 100 cases. Those outbreaks have been marked by exposures at schools and churches in communities with low vaccination levels.”
  • STAT News relates,
    • “Federal health officials on Wednesday [December 10] expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
    • “The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
    • ‘The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
    • “No deaths have been reported in the outbreak, which was announced Nov. 8.
    • “Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.”
  • and
    • “While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked.
    • Researchers sifted through previous Covid vaccine studies and identified a pair of immune signaling molecules, or cytokines, present at higher levels in the blood of vaccine recipients with myocarditis: CXCL10 and interferon-gamma (IFN-γ). The authors found that these signals could also be triggered in the lab when immune cells were exposed to the Pfizer and Moderna Covid vaccines, or when mice were inoculated.
    • “Scientists found that using antibodies to block CXCL10 and IFN-γ reduced signs of cardiac stress in vaccinated mice and in cardiac spheroids, three-dimensional growths of human cells meant to mimic some aspects of the heart’s structure and function. The authors also found they could block the cytokines’ effects with genistein, a compound found in soybeans and other legumes that has been linkedto reduced inflammation.
    • “The findings, published in the journal Science Translational Medicine, come as messenger RNA vaccines face scrutiny from the Trump administration and some lawmakers. That has forced researchers studying these shots to strike a tricky balancing act between reporting new insights on adverse events while making clear that the shots are safe overall.
    • “I want to emphasize this is very, very rare. This study is purely to understand why. In those rare cases, what’s going on? People talk about it, and here we provide a mechanism,” said Joe Wu, director of Stanford Cardiovascular Institute and the study’s senior author.”
  • Medscape tells us,
    • “As women age, they face several health risks related to the menopause transition. Treating these risk factors, which include obesity and high blood pressure, can reduce the risks for diabetes, cardiovascular disease (CVD), and other health problems.
    • “These risks also can be driven by age-related changes that occur around the time of menopause, said Marie K. Christakis, MD, MPH, assistant professor of obstetrics and gynecology and menopause and mature women’s health at the University of Toronto in Toronto, during a presentation at the Diabetes Canada and Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference 2025.
    • “Women at midlife are in what I term a cardiovascular storm,” she said. “More than 42% of American women between ages 40 and 59 years have a BMI over 30, and the prevalence of obesity is higher among women between ages 40 and 59 years. Generally, menopause occurs naturally between ages 46 to 54 years, and central adiposity is a particular issue.” 
  • MedPage Today notes,
    • “In a large phase III trial of adjuvant treatment for early-stage breast cancer, the investigational oral drug giredestrant reduced the risk of invasive disease recurrence by 30% versus standard endocrine therapy.
    • “Among more than 4,000 patients with hormone receptor (HR)-positive disease, 3-year invasive disease-free survival (IDFS) rates reached 92.4% with the next-generation oral selective estrogen receptor antagonist and degrader (SERD), as compared with 89.6% with standard of care (HR 0.70, 95% CI 0.57-0.87, P=0.0014).”
    • “The findings of the lidERA Breast Cancer trial mark the first benefit with a novel endocrine agent in early breast cancer in 20 years, not since the approval of aromatase inhibitors (AIs) in the 2000s, said Aditya Bardia, MBBS, MPH, of the University of California Los Angeles.
    • “Overall, the results support giredestrant as a potential standard endocrine option for patients with hormone receptor-positive breast cancer,” said Bardia, who presented the findings here at the San Antonio Breast Cancer Symposium.”
  • Fierce Pharma adds,
    • “Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.
    • “The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.
    • “Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.
  • and
    • “A year after a clutch of major pharmas threw their weight behind a new campaign devoted to addressing the serious health disparities facing Black breast cancer patients, “Care for HER” has been shown to have a tangible positive impact on patients’ lives.
    • “Touch, The Black Breast Cancer Alliance and Unite for HER—the two nonprofit organizations behind the program—presented a study about that impact at the San Antonio Breast Cancer Symposium on Wednesday.
    • “The research centers ran a survey of 57 participants in the Care of HER program, all Black women who have been diagnosed with breast cancer, 93% of whom said they’d used the program’s resources.”
  • Per Cardiovascular Business,
    • “Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
    • “While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
    • “Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS plans to launch a first-of-its-kind healthcare engagement platform, banking that perennial gripes about poor access and navigation will incentivize both consumers and rival companies to sign on.
    • “The platform will include data and services offered by CVS’ different health businesses — and those of participating industry partners. The goal is to create an integrated healthcare experience for consumers, hopefully enhancing their experience with the industry, lowering costs and improving outcomes, CVS executives said Tuesday during the healthcare giant’s investor day in Hartford, Connecticut. 
    • “CVS is also banking that the platform will also be a source of revenue by driving consumers to CVS products and services they might not know about otherwise.”
  • Kaufman Hall announced,
    • “Hospital volumes remained strong in October, while average length of stay declined, translating to a dip in net revenue per discharge. Bad debt and charity care continue to rise, and staffing levels are tightening.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • The American Journal of Managed Care lets us know,
    • “As states and federal programs accelerate the shift to value-based care, a new national survey suggests clinicians face a widening gap between policy expectations and the tools available to meet them.
    • “Tracking patient progress emerged as the biggest barrier—more than insurance—for mental health and primary care clinicians adapting to outcome-based payment models, according to October 2025 survey findings released by Twofold Health, an artificial intelligence (AI) clinical notetaking platform.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On December 17, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on January 14, 2026.”
  • Per MedTech Dive,
    • “Teleflex has struck deals to sell its acute care, interventional urology and OEM businesses for a combined $2.03 billion, the company said Tuesday.
    • “Montagu and Kohlberg, two private equity firms, are buying the OEM business for $1.5 billion. Intersurgical, an anesthesia and respiratory care medtech company, is buying the acute care and interventional urology businesses for $530 million.
    • “Needham analysts said in a note to investors that the total sale price is at the low end of their estimates. Yet RBC Capital Markets analysts told investors they view the update positively.”
    • * * * “Selling the units will leave Teleflex focused on its vascular access, interventional and surgical businesses. The company picked the businesses as the focus of its ongoing operations because they serve attractive, primarily hospital-focused end markets. Teleflex framed the split as a way to simplify its operating model and manufacturing footprint.”

Tuesday report

David Ermer–ACA, CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • MedPage Today reports,
    • “The number of Americans signing up for Affordable Care Act (ACA) health insurance for 2026 is moderately higher than it was at a similar time last year, initial new federal data show, even as subsidies set to expireopens in a new tab or window at the end of 2025 will make the coverage more expensiveopens in a new tab or window for many.
    • “Seen at face value, the data from the Centers for Medicare and Medicaid Services seem to defy predictions that many Americans facing pricier plans would drop out of marketplace coverage altogether next year. But experts caution that the numbers are an incomplete snapshot of total enrollment, which could still show a decline by the end of the open enrollment period.
    • “Overall, it’s just too early to know what any of this means,” said Jason Levitis, a senior fellow in the health policy division at the Urban Institute.
    • “The data released Friday show that by day 29 of the window for Americans to shop for ACA plans this year, nearly 5.8 million people had picked one. That’s nearly 400,000 more enrollments than by day 30 of the open enrollment period last year.
    • Meanwhile, this year’s enrollment numbers are about 1.5 million lower than the 7.3 million or so people who had signed up 32 days into the open enrollment period 2 years ago, showing there is some fluctuation year to year in when people sign up for coverage.
    • “In most states, for Americans who want coverage to start Jan. 1, the window to shop for ACA coverage began Nov. 1 and ends Dec. 15. People who want their coverage to start later can continue to select plans through Jan. 15.”
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said he would hold a vote later this week on a Republican measure aimed at controlling healthcare costs, amid party division over how best to head off big price increases next year for millions of households.
    • “Thune said Republicans have coalesced around legislation from Sens. Bill Cassidy (R., La.) and Mike Crapo (R., Idaho) [discussed in yesterday’s FEHBlog post] that would put as much as $1,500 a year into tax-advantaged health savings accounts when paired with lower-priced insurance plans in 2026 and 2027. The proposal doesn’t extend enhanced Affordable Care Act subsidies, which are due to expire after this year.
    • “The measure aims to provide an alternative to a Democratic proposal that extends the ACA subsidies for three more years. Votes on the two plans in the GOP-controlled Senate are set for Thursday, as Thune follows through on a promise made to Democrats as a condition for ending the government shutdown last month.
    • “So there will be something out there that Republicans will be able to talk about and support and vote for, and then we’ll see what happens Thursday,” Thune said. If neither proposal gets the 60 votes required to advance in the Senate, he said, “then we’ll see where it goes from there.”
  • Per a Senate news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is seeking information from stakeholders regarding the American Medical Association’s (AMA) monopoly of Current Procedural Terminology (CPT®) codes and its impact on patients, providers, and health care costs. Cassidy is asking stakeholders with relevant experience and knowledge of CPT ® coding contracts with the AMA to inform the Committee’s inquiry by responding to this questionnaire.
    • “As chair of the HELP Committee, Cassidy is using all tools at his disposal to lower costs for American patients. Thus far, the AMA evaded questions and failed to cooperate with Cassidy’s inquiry. If the AMA does not respond in a fulsome and transparent manner by December 15, 2025, the Chairman is committed to finding answers by other means.
    • “The federal government mandated the use of CPT codes. This creates the potential for abuse in that if someone has to buy your product, you can charge them what you want,” said Dr. Cassidy. “There may be nothing wrong here, but we should get answers to make sure the CPT system is working for the American patient and for the American health care system.”
  • Beckers Hospital Review tells us,
    • “Nearly 4 million Medicare-eligible Americans face heightened risk of disrupted medication access as restructuring efforts by the U.S. Postal Service slow mail delivery in rural and underserved communities reliant on mail-order prescriptions, according to a Dec. 4 analysis from The Brookings Institution
    • “In 2024, USPS launched its Regional Transportation Optimization initiative, which consolidates mail processing into regional hubs. While the initiative aims to improve efficiency, early analyses suggest it has exacerbated delivery slowdowns in rural areas, according to the report.”
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 9 issued a proposed rule that would make changes to the Increasing Organ Transplant Access Model beginning July 1, 2026. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1 of this year. To comply with statutory requirements, CMS proposes to modify the eligible kidney transplant hospital criteria to exclude Department of Veterans Affairs medical facilities and military medical treatment facilities. The agency also proposes to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. Regarding IOTA participant performance, CMS proposes updates to the composite graft survival rate metric, including adding a risk-adjustment methodology that includes several transplant recipient and donor characteristics. In addition, CMS proposes other policy changes related to repayments, the extreme and uncontrollable circumstances policy, transparency and public posting of information, voluntary health equity plans, beneficiary protections, monitoring activities, and remedial actions and termination.” 
  • Modern Healthcare relates,
    • “Health insurance companies spent two years getting ready for a new Medicare Advantage quality metric intended to tackle health disparities. Then the government pulled the plug.
    • “The Excellent Health Outcomes for All measure — also known as EHO4All and formerly known as the health equity index— likely won’t be part of the Medicare Advantage Star Ratings program in 2027 after all, the Centers for Medicare and Medicaid proposed in a draft regulation last month.
    • “It’s a mixed bag for the insurance sector. In conjunction with implementing EHO4All, CMS also planned to scrap the Star Ratings program’s so-called reward factor, which benefits companies that demonstrate high quality scores over multiple years. But other companies stood to gain from an emphasis on health equity. 
    • “Moreover, the industry at large carried out intensive preparations to boost their performance on EHO4All measures, which were intended to boost insurers that cover large numbers of beneficiaries who qualify for both Medicare and Medicaid, are eligible for low-income subsidies, or have disabilities.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has launched a safety review of approved respiratory syncytial virus therapies for infants, including Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck, Reuters reported Dec. 9.
    • “Senior executives from the three companies were informed last week that the agency would seek further data on the therapies following internal concerns raised by FDA officials appointed under Health and Human Services Secretary Robert F. Kennedy Jr. Tracy Høeg, MD, PhD, recently namedacting director of the FDA’s Center for Drug Evaluation and Research, initiated the safety inquiry over the summer. As a noted vaccine skeptic, the appointment of Dr. Høeg has raised serious concerns among healthcare experts.”
  • Bloomberg Law lets us know,
    • “The FDA’s effort to curb high drug costs by accelerating approvals of cheaper medicines similar to expensive biologics will need other policy reforms to boost access to the biosimilars, drug pricing experts say. 
    • “The Food and Drug Administration is seeking to lower drug costs by simplifying the development of biosimilars, products that are highly similar to FDA-approved biologics, have no clinically meaningful differences, and can treat patients the same way. Biologics, such as AbbVie Inc.‘s blockbuster treatment Humira for rheumatoid arthritis and Merck & Co.‘s cancer medicine Keytruda, are complex drugs made from sources such as plant or animal cells. 
    • “Biosimilars are often available at a lower cost compared to biologics. While insurance varies for patients, the list price of Humira can run above $6,000 a dose. Amgen Inc.‘s Amjevita, a biosimilar to the inflammatory drug, can be purchased at either 55% or 5% below Humira’s list price.
    • “The FDA action, however, might not immediately yield patient access to the cheaper medicines without reforming other policies that seek to make biosimilars available upon approval, drug pricing experts say. Biosimilars often face hurdles before hitting the market, frequently due to patent litigation, agreements between drug companies to defer entry, and how they’re treated in health insurers’ prescription drug plans.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application.
    • “Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we’re entering a new era of manufacturing here at home,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security.”
    • “The Augmentin XR application demonstrated clear alignment with the CNPV program’s national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. This approval will also help address antibiotic shortages in the U.S. that have plagued the healthcare system over the past two decades.”
  • and
    • “The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “The FDA continues to exercise flexibility in the regulatory approach for rare diseases by considering all available data sources, including as appropriate data from expanded access programs, to facilitate the advancement of life-changing treatments while ensuring scientific requirements are satisfied.”
  • Per MedTech Dive,
    • “Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated into its wellness wristband illustrates the challenges wearables developers face as they add increasingly sophisticated features.
    • “Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.
    • “The company has pushed back on the warning letter, however, arguing that blood pressure is a wellness feature. The FDA disagreed, saying blood pressure is inherently related to a medical diagnosis. 
    • “The FDA isn’t likely to concede on its challenge, experts said. Whoop’s skirmish with the FDA offers lessons on where to draw the line between wellness and medical features.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Justice Department is weighing a challenge to a deal between two of the largest companies offering software to small, independent pharmacies, as antitrust enforcers step up their focus on the health-care industry.
    • “The deal, which the companies didn’t publicly announce, involves the acquisition ofMicro Merchants Systems, the operator of pharmacy management software platform PrimeRx, by RedSail Technologies, said the people, who asked not to be named discussing a confidential matter. Micro Merchants is backed by TA Associates Management, while RedSail is the result of multiple acquisitions backed by investment firms including Francisco Partners. 
    • “Representatives of the companies met with DOJ antitrust chief Gail Slater in late November, said the people. Such meetings indicate significant government opposition to a deal, although they don’t always precede a federal lawsuit if the companies are able to make proposals that allay the agency’s concerns. Companies submit confidential filings to US authorities as part of a merger review process.”
  • STAT News relates,
    • “In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs.
    • “Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.” * * *
    • “Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines, according to legal experts following the issue.”
  • The Wall Street Journal brings us to date on Luigi Mangione’s evidence hearing in New York state court.

From the public health and medical / Rx research front,

  • ABC News reports,
    • “Concerns about the flu spreading in the U.S. are growing as the U.K. continues to see a spike in cases among children and young adults.
    • “The increased number of cases in the U.K., could be a predictor for the flu season in the U.S., according to ABC News chief medical correspondent Dr. Tara Narula.
    • “We know that England or other places can be a marker for what is going to happen here, because their flu season happens a few weeks earlier than ours,” Narula said on “Good Morning America” Monday, adding, “We have low numbers of cases so far but they are increasing.”
    • “Some hospitals are starting to implement flu season visitor restrictions, including the Detroit Medical Center and Children’s Hospital of Michigan, which are allowing, as of Monday, up to two visitors per patient and only those 13 years of age and older are permitted on inpatient hospital floors or in observation units.
    • “According to data from the Centers for Disease Control and Prevention, flu activity in the U.S. is up at least 7% in the last week, and so far, there have been nearly 2 million illnesses, 19,000 hospitalizations, and 730 deaths from the flu.”
  • The Green Science Policy Institute tells us,
    • “New research led by the California Department of Public Health and partners found that replacing foam-containing furniture made before 2014 would cut in half levels of certain harmful flame retardants in people’s bodies in just over a year. Published today in the peer-reviewed journal Environmental Pollution, the study is the first to show measurable health benefits from California’s 2014 furniture flammability standard update, which made it possible for manufacturers to comply without adding chemical flame retardants.
    • “Specifically, volunteers who swapped their old sofas and living room chairs for new, flame-retardant-free versions saw their blood concentrations of polybrominated diphenyl ethers (PBDEs) drop by half in just 1.4 years. Due to the overall declining use of these chemicals, levels in participants who did not replace furniture dropped as well, but two to four times more slowly. PBDEs are linked to cancer risk, hormone disruption, and neurodevelopmental effects. Epidemiological studies have shown that the average U.S. child has lost three to five IQ points from exposure to one PBDE. Further, a recent research paper estimated those with highest levels of this flame retardant in their blood had about four times the risk of dying from cancercompared with people with the lowest levels.
    • “This study shows that the update to California’s flammability standard not only changed what goes into furniture—it changed what goes into people’s bodies,” said co-lead author Kathleen Attfield, a Research Scientist Supervisor with the California Department of Public Health. “Through biomonitoring, we can assess how policy changes and consumer choices can work together to lower exposures to toxic chemicals.”
  • NBC News reports,
    • “Despite previous excitement around a potential link between GLP-1 drugs and a reduced risk of cancer, new research suggests the popular medications “probably have little or no effect” on a person’s risk of developing one of the 13 obesity-related cancers.
    • “The findings, published Monday in the Annals of Internal Medicine, may seem counterintuitive, said co-author Dr. Cho-Han Chiang, who conducted the study earlier this year as an internal medicine resident at Mount Auburn Hospital, a Harvard Medical School teaching hospital in Cambridge, Massachusetts.” * * *
    • “The new study has two major limitations, Chiang said. One is that none of the nearly 50 trials his team analyzed was designed to measure cancer outcomes.
    • “Dr. Kandace McGuire, chief of breast surgery at the Massey Comprehensive Cancer Center at Virginia Commonwealth University, said that might explain the counterintuitive nature of the findings.
    • “When you take a bunch of studies that weren’t looking at cancer risk and you throw them together, sometimes you find things that are contrary to what you would hypothesize,” said McGuire, who wasn’t involved in the research. “Some of that may be just the makeup of the studies, rather than the actual data itself.”
    • “From a cancer prevention perspective, I think more data is needed,” Chiang said, noting that there’s also a lack of data on GLP-1 usage among patients who already have cancer.”
  • Health Day points out,
    • “Laughing gas might live up to its name for people struggling with depression, a major new study says.
    • “Treatment with nitrous oxide can provide rapid relief for people with depression, especially those who aren’t helped by antidepressants, researchers reported recently in the journal eBioMedicine.
    • “This is a significant milestone in understanding the potential of nitrous oxide as an added treatment option for patients with depression who have been failed by current treatments,” senior researcher Dr. Steven Marwaha, an academic psychiatrist with the University of Birmingham in the U.K., said in a news release.
    • “This population has often lost hope of recovery, making the results of this study particularly exciting,” Marwaha added.”
  • Today was the last day of the 2025 American Society for Hematology conference.
    • Per BioPharma Dive,
      • “A regimen involving Johnson & Johnson’s dual-acting drug Tecvayli could be curative when used early in the disease course of people with multiple myeloma, according to data disclosed Tuesday.
      • “Released at the annual meeting of the American Society of Hematology in Orlando, the results come from a trial called MajesTEC-3. J&J in October claimed early success for the study, which evaluated Tecvayli alongside another J&J drug called Darzalex, against Darzalex and a standard combination in people whose disease had advanced after one to three treatment lines. But it didn’t provide specific details, saving them for a spotlighted presentation at ASH on Tuesday.
      • “According to those results, the Tecvayli-Darzalex combination cut the relative risk of disease progression or death by 83% when compared to Darzalex and other therapies. Progression was also uncommon for treatment recipients who went six months without relapsing. According to J&J, 90% of those enrollees were still progression-free three years after the study’s start, leading researchers to suggest the combination could have curative potential.
      • “The efficacy is truly remarkable with this combination,” said Surbhi Sidana, an associate medical professor at Stanford University and a trial investigator. “We can see a light at the end of our tunnel with all of these therapies for our patients, having maybe a functional cure in the future.”
  • BioPharma Dive adds,
    • “An experimental Novartis drug helped bring an autoimmune condition causing low platelet counts under control in a Phase 3 trial, further lifting the prospects of a therapy the company acquired in a multibillion-dollar deal last year.
    • “The drug, ianalumab, acts by destroying misfiring immune cells and blocking signaling that creates new ones. Novartis has been testing it in a disorder called immune thrombocytopenia, in which the body erroneously wipes out blood-clotting platelets. The company intends for the drug to work hand-in-hand with another therapy, Promacta, that it sells for the condition.”

From the U.S.healthcare business front,

  • Fierce Healthcare reports,
    • “Healthcare giant CVS Health boosted its outlook for the year as part of its investor day on Tuesday.
    • “The company said it now expects full-year revenues of at least $400 billion and earnings per share (EPS) between $6.60 and $6.70. Previous estimates projected at least $397.3 billion in revenue and EPS of $6.55 to $6.65.
    • “CVS also projects its compound annual growth rate to be in the mid-teens for the next three years, reflecting the efforts it’s made to improve performance at multiple units. For example, CVS said it’s on track to return to target margins at Aetna, and it’s driving sustained earnings at CVS Pharmacy.
    • “We are closing out 2025 with meaningful momentum across our businesses and we expect another year of strong earnings growth in 2026,” said Chief Financial Officer Brian Newman in a press release. “We are committed to doing what we say.”
  • Fierce Pharma tells us,
    • “Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities that it plans to build in the U.S.
    • “The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will produce active pharmaceutical ingredients (APIs) for peptide and small-molecule medicines, including the highly anticipated GLP-1 weight-loss pill, orforglipron.
    • “Lilly plans to employ 450 at the complex, including engineers, scientists, operations personnel and lab technicians. The Indianapolis-based company expects to begin construction in 2026 and complete the facility in 2032. Lilly estimated that the project will also generate 3,000 construction jobs.”
  • Beckers Hospital Review informs us,
    • “Pfizer has entered into a global collaboration and license agreement with YaoPharma for the development, manufacturing and commercialization of YP05002, a small-molecule GLP-1 receptor agonist currently in phase 1 development for chronic weight management.
    • “YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical Group, will complete the ongoing phase 1 clinical trial and grant Pfizer exclusive worldwide rights to further develop and commercialize the therapy, according to a Dec. 9 news release.
    • “Pfizer will pay $150 million upfront and may pay up to $1.935 billion in development, regulatory and commercial milestone payments, along with tiered royalties on sales if the therapy is approved.”
    • Fierce Health relates,
      • “Artificial intelligence was a key theme in a session on how digital tools are changing the payer industry at this year’s Fierce Health Payer Summit.
      • “The panel took place last Thursday at the annual event and was moderated by Staff Writer Emma Beavins. The panelists spoke about the importance of improving payer-provider relationships and the member experience through AI and data-sharing.
      • “Consumers are used to the convenience offered by platforms like Netflix and Amazon, yet healthcare is lagging. AI can help streamline the member experience, including by surfacing transparent pricing. Doing so carries a high return on investment, Brittany Poche, director of solutions at revenue cycle management company Norwood, said. “Having that whole transparency and that experience, that is going to really move us,” Poche said on the panel.”

    Monday report

    David Ermer–ACA, Congress, FDA, Medical / Rx research, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

    From Washington, DC,

    • Per a Senate news release,
      • “U.S. Senators Mike Crapo (R-Idaho), chair of the Senate Finance Committee, and Bill Cassidy, M.D. (R-Louisiana), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, unveiled the Health Care Freedom for Patients Act, historic Republican legislation to lower health care costs and give money directly to families to control their own care. This bill is an alternative to Democrats’ temporary COVID bonuses, which send billions of tax dollars to giant insurance companies without lowering insurance premiums.
      • “Giving billions of taxpayer dollars to insurers is not working to reduce health insurance premiums for patients,” said Senator Crapo. “We need to give Americans more control over their own health care decisions. This bill builds on the work we did in the Working Families Tax Cuts Act and will help Americans manage the rising cost of health care without driving costs even higher.”
      • “Instead of 100 percent of this money going to insurance companies, let’s give it to patients. By giving them an account that they control, we give them the power. We make health care affordable again,” said Dr. Cassidy.
      • “This legislation:
        • “Sends money to patients, not giant insurance companies;
          • “Americans on affordable bronze and catastrophic plans would access these dollars in a Health Savings Account (HSA).
          • “These funds cannot be used for abortion or dangerous gender transitions.
        • “Lowers insurance premiums by funding cost-sharing reduction (CSR) payments [beginning in 2027};
        • “Empowers Americans to choose the insurance plan that fits their needs by increasing access to low-cost catastrophic plans;
        • “Prevents illegal immigrants from accessing Medicaid by requiring states to verify citizenship and immigration status before coverage; and
        • “Stops taxpayer dollars from funding gender transition services under Medicaid and excludes them as an essential health benefit for plans sold on the Obamacare exchanges.” * * *
      • Click here for a one-pager.
      • Click here for bill text.
    • MedPage Today reports,
      • “Members of the Medicare Payment Advisory Commission (MedPAC) generally responded favorably Thursday to a draft recommendation to increase reimbursement in 2027 for physicians who treat Medicare patients — with one exception.
      • “The MedPAC chairman’s draft recommendation was to “increase payment rates for physician and other health professional services by 0.5 percentage points more than current law.” However, commission member Brian Miller, MD, MPH, of Johns Hopkins University in Baltimore, pointed out that last year, “[MedPAC’s recommended] physician fee schedule update … was a net update of 3%.”
    • Govexec tells us,
      • “The Trump administration laid out its plans to “end weaponized government” in its new management agenda released Monday. 
      • “The latest President’s Management Agenda includes goals to eliminate “woke” programs, downsize the government workforce and real estate portfolio, implement workforce reforms and modernize government technology, as well as targets to “annihilate government censorship of speech” and centralize government contracting.
      • “The agenda reflects much of the Trump administration’s longstanding priority to drastically reshape the government, an objective the White House focused on immediately after the inauguration through its Department of Government Efficiency.”

    From the Food and Drug Administration front,

    • Per an FDA news release,
      • “The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  [The manufacturer is Gamida Cell Ltd.]
      • “This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one’s life course,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Severe aplastic anemia is a rare blood disorder that can be fatal, and the FDA remains committed to expanding treatment options for patients with this disease.”  
    • CNN adds,
      • “Medical technology company MED-EL announced Thursday [December 4] that the US Food and Drug Administration has approved expanding the use of its Synchrony cochlear implants to children as young as 7 months who have bilateral profound sensorineural hearing loss. The implants were previously indicated for 9 months and older.”

    From the judicial front,

    • The Wall Street Journal reports,
      • “The Supreme Court seemed poised Monday to expand the president’s power to fire the heads of many regulatory agencies, even as one pivotal justice expressed a desire to insulate the Federal Reserve from political pressure.
      • “During 2½ hours of oral arguments, the justices probed the limits of President Trump’s assertion of virtually unfettered authority to remove agency leaders, despite federal laws that protect them from being fired over policy disagreements.
      • “Justice Brett Kavanaugh pointedly asked Solicitor General D. John Sauer about concerns from economists that a broad victory for Trump in the case would jeopardize the independence of the Fed’s board of governors.
      • “I share those concerns,” said Kavanaugh, a Trump appointee.
      • “Still, Kavanaugh and the other five conservative justices were, as expected, mostly receptive to the administration’s argument that the president is entitled to more control over dozens of regulatory bodies in the executive branch, such as the Federal Trade Commission and the National Labor Relations Board.”
    • The Supreme Court is expected to announce its decision toward the end of the current term in June 2026.

    From the public health and medical / Rx research front,

    • The Wall Street Journal reports,
      • “Brayan Garcia was driving along a highway in his red Toyota Corolla when he slammed into the back of a Ram pickup truck that was stopping at an intersection in West Texas.
      • “Garcia, 22, died at the scene of the early morning crash. His Corolla sustained heavy damage, its hood ripped off entirely. Debris was scattered across several lanes. But despite hitting the truck directly, the Corolla’s air bags never went off.
      • “Toyota had recalled Garcia’s car in 2020 over a dangerous defect that could stop its air bags from deploying. But Garcia’s vehicle hadn’t gotten the fix, like millions of others currently on the road. 
      • “From 2015 to 2024, about 12 million vehicles were recalled for safety defects that could result in air bags not deploying. These recalls—37 in total—included models made by General Motors and Ford as well as luxury brands such as Mercedes-Benz and Audi. 
      • “About 2.6 million, or around 22%, of affected vehicles remain unfixed, according to an analysis of the latest National Highway Traffic Safety Administration data by The Wall Street Journal.
      • “The Journal found 12 people, including Garcia, who died after crashes in Toyotas and other vehicles where the air bag was under recall, hadn’t been repaired and didn’t deploy. 
      • “The NHTSA data reveal a broader problem: Roughly one in three cars recalled for all reasons goes unfixed. The rate is roughly the same even for serious flaws such as failing brakes, engine fires or the air bag defects reviewed by the Journal.”
    • The New York Times relates,
      • “The statistics are incontrovertible: Since 1992, the diagnoses of eight cancers has doubled in the United States in patients under age 50, including cancers in the thyroid, anus, kidney, small intestine, colorectum, endometrium and pancreas, as well as the blood cancer myeloma. Other types, including breast cancer, also are on the rise.
      • “The magnitude and speed at which early onset cancer incidence has increased is unlike most cancer trends ever observed (the possible exception being cigarette smoking and lung cancer),” the American Association for Cancer Research said in its announcement of a special conference being held this week that will explore the rise in cancers among younger people.
      • “The sharp uptick has been agonizing for these younger patients and many of their doctors.
      • ‘The patients wonder: Why did I develop cancer? And how will my life be transformed by potentially excruciating treatments?
      • “Their doctors share these questions, and some have additional concerns: What if these cancers had never been detected? Are doctors offering treatments to younger patients with early-stage diseases that may do as much harm as good?”
    • The Washington Post tells us,
      • “Children who returned to in-person schooling during the coronavirus pandemic saw improvements in their mental health, according to a new study that found school reopenings were associated with significant declines in diagnoses of anxiety, depression and other conditions.
      • “The findings, the study authors say, underscore that the social structure and support schools provide protected children’s mental well-being during the pandemic.
      • “Researchers from the Harvard T.H. Chan School of Public Health and Elevance Health, which is a private health insurer in California, analyzed medical claims for more than 185,000 California children ages 5 to 18 between March 2020 to June 2021. Before schools reopened about 5,200 children had a mental health diagnosis and that numbers rose to 6,500 over the course of the pandemic.
      • “But the researchers said after schools reopened, trends in mental health diagnoses, medications and spending dropped relative to trends in schools that stayed closed.”
    • Health Day informs us,
      • “The U.S. stillbirth rate dropped slightly last year, offering some hope after several years of uncertainty, according to new data from the U.S. Centers for Disease Control and Prevention (CDC).
      • “The report, released Dec. 3, found a 2% decline in stillbirths in 2024. Even with that improvement, nearly 20,000 pregnancies ended in fetal death. That’s equal to about 5.4 stillbirths for every 1,000 pregnancies lasting 20 weeks or longer.
      • “This is the lowest national rate seen in decades, although the CDC said that it does not necessarily break previous records.”
    • The American Medical Association lets us know “What doctors wish patients knew about strep throat.
      • “What is causing that sore throat? It could be strep, and it needs to be treated the right way. Two Ochsner Health physicians share more about strep throat.”
    • Per Healio,
      • “In an analysis adjusted for tobacco cigarette use, the likelihood for asthma and COPD significantly rose with daily cannabis inhalation over a 30-day period, according to results published in Journal of General Internal Medicine.
      • “I hope these results give clinicians more confidence in stating that there are serious concerns about negative health impacts of inhaling cannabis on the lungs,” Alison S. Rustagi, MD, PhD, adjunct assistant professor at University of California, San Francisco, told Healio.
      • “We don’t have enough information now to say there’s a causal link, but we also have reason to think that there may be harm to the lungs from cannabis,” she continued. “This is important for patients to know as they make health decisions.”
    • From the American Society of Hematology conference, now underway in Orlando, Florida,
      • Per BioPharma Dive,
        • “An experimental drug from Terns Pharmaceuticals is showing it may emerge as a threat to multiple established medicines for a slow-growing blood malignancy known as chronic myeloid leukemia. 
        • “According to results presented at the American Society of Hematology meeting on Monday, Terns’ drug, codenamed TERN-701, helped a majority of study participants with CML who had received previous treatments significantly reduce the number of diseased white blood cells in their bloodstream. The findings suggest the drug, a type of targeted, oral treatment, may eventually be competitive with widely used medicines like Novartis’ Scemblix, which is expected to generate more than $4 billion in peak yearly sales.”
      •  and
        • Eli Lilly was the last company to bring to market a so-called BTK inhibitor for leukemia and lymphoma. But study results revealed Sunday show Lilly’s medicine may be more effective — and potentially safer — than the oldest drug in its class. 
        • The data come from a study testing Lilly’s Jaypirca directly against AbbVie and Johnson & Johnson’s Imbruvica. Early results presented at the American Society of Hematology meeting suggest Jaypirca helped induce responses in more people with chronic lymphocytic leukemia or small lymphocytic lymphoma than Imbruvica. More definitive measures of impact — such as effects on disease progression and survival — are pointing in Jaypirca’s favor as well, though additional follow-up testing is needed to confirm those benefits.
        • “The results could be crucial in helping Lilly boost sales of Jaypirca as Imbruvica, which was launched in 2013 and has since been a regular blockbuster, approaches the end of its patent life.”
      • Per STAT News,
        • “With so-called menin inhibitors now approved for patients with certain types of advanced acute myeloid leukemia, research efforts are shifting to find uses for the genetically targeted drugs in newly diagnosed patients.
        • “Kura Oncology presented preliminary results today from a study that combines Komzifti, its menin-blocker, with two standard AML treatments. In an analysis that encompassed 40 patients with newly diagnosed, menin-susceptible AML, the triplet regimen showed a complete remission rate of 86% with a manageable safety profile.
        • “Syndax Pharma reported results from its own menin-inhibitor combination study in newly diagnosed AML patients on Saturday at the ASH meeting.”
    • Per Fierce Pharma,
      • “UCB plans to file for regulatory approval of Fintepla to treat a third epileptic condition “as soon as possible,” the company said, as it reported results of a phase 3 trial in patients with the ultra-rare cyclin-dependent kinase-like-5 (CDKL5) deficiency disorder.
      • “The study of 87 patients aged 1 to 35 with CDKL5 achieved its primary endpoint, as Fintepla demonstrated a statistically significant reduction in seizures compared with placebo. The trial also achieved two of its three secondary objectives, the Brussels-based company said at the American Epilepsy Society (AES) conference in Atlanta.
      • “Fintepla was first approved in 2020 to treat seizures associated with Dravet syndrome (DS), a rare, severe form of epilepsy that affects roughly 20,000 in the U.S. Two years later, Fintepla gained expansion into a larger epilepsy indication, Lennox-Gastaut syndrome (LGS), which affects approximately 48,000 in the U.S. In both indications, the cherry-flavored oral solution is cleared for patients age 2 and older.”
    • Per a National Institutes of Health news release,
      • “A study funded in part by the National Institutes of Health (NIH) has revealed important insights into the genetics of deposits in the eye, known as reticular pseudodrusen (RPD), that are linked to greater risk of vision loss among people with age-related macular degeneration (AMD). The study underscores that AMD is not one disease and highlights the need for novel treatment approaches.
      • “This study could help explain why drugs that target just the complement pathway have shown a minimal effect in slowing geographic atrophy,” said Anand Swaroop, Ph.D., chief of the Neurobiology Neurodegeneration and Repair Laboratory at NIH’s National Eye Institute (NEI) and a coauthor of the study report. “It’s clear that AMD involves multiple pathways that differentially synergize to generate distinct phenotypes.”
    • Per the Genetic Engineering and Biotechnology News,
      • “Terray Therapeutics has achieved its first discovery milestone in the company’s multi-target collaboration with Bristol Myers Squibb (BMS). Under the terms of the agreement, which began in 2023, Terray will discover and develop small molecule compounds against a set of targets nominated by BMS. BMS will subsequently assume responsibility for development and commercialization. 
      • “While therapeutic details of the milestone have not been disclosed, Terray describes the target as “novel and difficult to drug,” and representative of the company’s Experimentation Meets Machine Intelligence (EMMI) platform.”  
    • Beckers Hospital Review calls attention to “23 recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

    From the U.S. healthcare business and artificial intelligence front.

    • Modern Healthcare unveiled its 2025 list of the top 100 most influential people in healthcare. Here are the top five:
      • 1. Sam Altman, co-founder and CEO, OpenAI
      • 2. Greg Adams, Chair and CEO, Kaiser Permanente
      • 3. Judy Faulkner, founder and CEO, EPIC Systems
      • 4. Stephen Hemsley, Chair and CEO, UnitedHealth Group
      • 5. Eugene Woods, CEO, Advocate Health
    • STAT News reports,
      • “Health insurance companies have lamented fast-rising medical expenses for more than two years. This year is no different as Americans continue to get more carethan insurers expected. 
      • “One of the main culprits of that higher spending: prescription drugs, and GLP-1s in particular.
      • “Some insurers spent more on drugs in the first nine months of this year than they did in all of 2024, financial documents analyzed by STAT show. For many, drug expenses are up more than 20% in 2025. The proliferation of GLP-1s — the injectable drug blockbusters that lead to substantial weight loss — has played a leading role and has led insurers and employers to consider whether they should stop covering them completely.” * * *
      • “Cynthia Cox, a vice president at health policy and research organization KFF who has studied health care spending across all types of health insurance markets, said GLP-1s are pressuring pretty much every insurer. “It’s not all GLP-1s, but I think a lot of the growth is,” she said.” 
    • The Wall Street Journal adds,
      • “Drugmakers are moving to sell their medicines directly to patients, abandoning the middlemen they have long relied on.
      • “The shift is a huge departure from how pharmaceutical companies including Eli Lilly, Novo Nordisk and Pfizer have sold drugs for decades and threatens the multibillion-dollar business of firms that have traditionally filled prescriptions. 
      • “It is saving some patients hundreds of dollars off the cost of prescriptions because companies have been lowering the prices for drugs sold directly. 
      • ‘Meantime, drugmakers who have been rolling out the services in recent months see a big opportunity to boost sales, though they risk losing revenue if they don’t offset lower prices by selling to more patients. 
      • “For the first time, pharma is actually looking end-to-end at the full patient journey,” said Pratap Khedkar, chief executive of pharmaceutical consulting firm ZS. “That is a very different mindset than has been the case for the last 50 years.”  
    • Brown & Brown has made available the 2026 edition of its Employer Health and Benefits Strategy Survey.
    • Fierce Healthcare tells us how “CommonSpirit Health is working to accelerate its recently launched turnaround plan.”
    • Cardiovascular Business points out,
      • “Edwards Lifesciences held its annual investor conference, predicting considerable sales growth in 2026 and highlighting the company’s continued momentum in the area of structural heart disease. Transcatheter aortic valve replacement (TAVR) and transcatheter tricuspid valve replacement (TTVR) are two areas expected to experience significant growth in the year ahead. 
      • “For 2026, Edwards Lifesciences is currently projecting overall sales growth of 8% to 10%  in addition to an adjusted earnings per share of $2.80 to $2.95. TAVR sales are expected to play a major role thanks to the continued success of its Sapien 3 platform and the planned JenaValve acquisition first announced in July 2024. In fact, the company projects TAVR sales to hit anywhere between $4.6 billion and $4.9 billion in 2026, good for a growth rate of 6% to 8%, respectively. Edwards Lifesciences also pointed to progress in the use of TAVR for patients with aortic regurgitation as a crucial step forward for patient care. 
      • “In addition, transcatheter tricuspid and mitral valve technologies are expected to hit sales of $740 million to $780 million, up 35% to 45% compared to 2025. On the tricuspid side of things, the company’s Evoque device for TTVR represents a particularly important piece of the puzzle, with two-year data on the valve expected by the second quarter of 2026.”
    • Beckers Payer Issues informs us,
      • “Elevance Health has rolled out its virtual assistant to 22 million commercial members, with a Medicare expansion planned for 2026.
      • “The tool, accessible through the Sydney Health app and affiliated plan websites, allows members to ask plain-language questions about coverage, costs, and providers. For example, members can inquire whether a surgery is covered and receive personalized cost estimates, a coverage breakdown, and a list of in-network providers, according to a Dec. 5 news release.
      • “The rollout is part of Elevance’s broader AI push across its operations. The company has deployed AI tools for internal workflows, call center automation, and clinical decision-making. The company has said it plans to invest several hundred million dollars in AI and digital initiatives.”

    Weekend update

    David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

    From Washington, DC,

    • The Senate is expected to pass S. Res. 520 which is bloc approval of over eighty nominations below the Cabinet or federal judicial level that require Senate approval.
    • Roll Call tells us about upcoming activities on Capitol Hill this week.
    • Modern Healthcare reports,
      • “States are using limited resources to mitigate the effects of rising health insurance exchange premiums and shrinking subsidies.
      • “Initiatives include financial assistance, reinsurance programs and intensified consumer outreach.
      • “Congress continues to debate whether to extend enhanced premium subsidies that expire at the end of the year.”
    • The New York Times relates,
      • “The new Dietary Guidelines for Americans will not arrive until early 2026, a representative for the Department of Health and Human Services told The New York Times on Thursday, marking a delay of the release of the government’s official advice on what to eat and drink for good health.
      • “For months, Robert F. Kennedy Jr., the nation’s health secretary, has promised to overhaul the guidelines. Federal law requires that they are updated every five years; the current edition was supposed to be replaced by the end of 2025.”
    • The Federal Benefits Open Season ends tomorrow December 8 on the following OPM established schedule:
      • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 8, 2025 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday December 8, 2025.”
    • OPM’s Director Scott Kupor added a new post to his Secrets of OPM blog last Friday. Here is a link to the post which concerns employee performance management.

    From the judicial front,

    • Tomorrow, the U.S. Supreme Court will hold its oral argument in Case No. 25–332, captioned Donald J. Trump, President of the United States, et al. v. Rebecca Kelly Slaughter, et al. Amy Howe, writing in the SCOTUSBlog, offers an explainer about the case.
      • “On Monday, Dec. 8, the Supreme Court will hear oral arguments in Trump v. Slaughter, a battle that has been brewing, on one hand, since soon after President Donald Trump took office in January and, on the other hand, for years. At the center of the battle are laws that limit the president’s ability to fire the heads of independent, multi-member federal agencies like the Federal Trade Commission. The president and his supporters are proponents of a doctrine known as the “unitary executive” theory – the idea that the president should have complete control over the executive branch. Under this theory, the president should be able to fire any member of the executive branch, and laws – like the one at the center of this case – that restrict his ability to do so violate the constitutional separation of powers between the three branches of government.” 
    • Federal News Network adds,
      • “A three-judge panel ruled Friday that President Donald Trump’s firings without cause of Cathy Harris and Gwynne Wilcox, Democratic members on the Merit Systems Protection Board and the National Labor Relations Board, were lawful.
      • “The split 2-to-1 panel decision of the D.C. Circuit Court of Appeals has no immediate effect, since both Harris and Wilcox’s firings were finalized in May. But Friday’s ruling comes as the Supreme Court is expected to hear arguments [on Monday December 8] on whether to overturn a 90-year-old ruling known as Humphrey’s Executor — a decision that could expand Trump’s [and future Presidents’] power to shape independent agencies.”
    • These court decisions do not affect OPM which is considered an executive agency subject to Presidential authority.

    From the public health and medical / Rx research front,

    • The New York Time reports that a kidney recipient dies after transplant from organ donor who had rabies. Only four donors have transmitted rabies to organ transplant recipients since 1978, according to federal officials.
      • “Since 1978, four organ donors have passed rabies to 13 organ recipients, the report said. Of the 13 recipients, six who received treatment for rabies survived. The seven others, who did not receive treatment, died.
      • “Fewer than 10 human deaths are attributed to rabies each year in the United States, according to the C.D.C. More than 3,500 animals test positive for the virus annually.
      • “In 2024, a record 48,149 organ transplants were performed, according to the Organ Procurement and Transplantation Network, the United Network for Organ Sharing reported. The organs came from a total of 24,018 deceased and living donors.”
    • The Wall Street Journal informs us,
      • “Despite being among the great scientific breakthroughs of all time, vaccines are under fire as top government officials cast doubts on their safety. 
      • “But as doctors and vaccine deniers spar over the safety of vaccines, emerging evidence finds that some vaccines aren’t only good at preventing the disease or virus they target but also might have broader or even unrelated health benefits.” * * *
        • “The shingles vaccine might reduce dementia risk, with one study showing it averted one in five new dementia diagnoses over seven years.
        • “A Nature study found that some cancer patients who received the Covid-19 vaccine while undergoing immunotherapy had a greater survival rate than those who didn’t.
        • “The BCG tuberculosis vaccine is being studied for Alzheimer’s prevention and has been shown to decrease infant mortality.”
    • A Washington Post recounts undergoing a full body MRI as a preventive measure which by the way is not covered by health insurance.
    • From the American Society of Hematology conference, now underway in Orlando, Florida,
      • Per Fierce Pharma,
        • “Pfizer has unveiled phase 3 results that could help the company’s hemophilia drug Hympavzi level the playing field in its competition with Sanofi’s Qfitlia and Novo Nordisk’s Alhemo.
        • “After an FDA approval about a year ago for the treatment of hemophilia in patients without inhibitors, Pfizer now has detailed data showing prophylactic Hympavzi can outperform traditional therapies at controlling bleeding in patients with inhibitors.”
      • Per BioPharma DIve,
        • “Vertex Pharmaceuticals’ genetic medicine Casgevy hit an early goal in two late-stage trials focused on children with uncommon blood disorders, helping them avoid damaging vessel blockages and the need for transfusions in a setting expected to be among the first to receive an extra-speedy review from the Food and Drug Administration.
        • “The data, disclosed Saturday at the American Society of Hematology scientific meeting in Orlando, may help boost disappointing sales for Casgevy, the first therapeutic to use CRISPR gene-editing technology to modify human diseases. Casgevy is a cell therapy made from patients’ own tissues and engineered to embed in the bone marrow and stimulate a protein called fetal hemoglobin. In sickle cell disease, this protein prevents the characteristic bending that results in blockages, while, in another disorder called beta thalassemia, it can prevent anemia and the need for frequent transfusions.”
      • Per STAT News,
        • “With sales of its existing blood cancer CAR-T therapies weakening, Gilead Sciences needs anito-cel, its next CAR-T therapy for multiple myeloma — to succeed more than ever. 
        • “On Saturday at the annual meeting of the American Society of Hematology, the company and its partner Arcellx reported deepening and durable responses with no concerning safety issues in the latest analysis of a pivotal-stage clinical trial.
        • “Among 117 patients enrolled in the study, 96% showed a tumor response, with 74% of patients achieving complete remission, the companies said in a press release. 
        • “Anito-cel delayed the worsening of multiple myeloma in 67% of patients at 18 months. At the same time point, 88% of the multiple myeloma patients in the study were still alive. 
        • “None of the study participants experienced delayed neurotoxicity, including Parkinsonian symptoms and cranial nerve palsies, and there were no cases of enterocolitis, an inflammation of the intestines.”
      • and
        •  “Revuforj is a pill made by Syndax Pharma that blocks a protein called menin implicated in certain types of genetically altered acute myeloid leukemia, or AML, an aggressive and difficult-to-treat blood cancer that occurs when immature bone marrow cells fail to mature into healthy blood cells and instead start dividing uncontrollably.
        • “For now, Revuforj is approved for patients with menin-susceptible AML that is no longer responsive to other therapies. On Saturday, however, a researcher presented preliminary study results showing strong efficacy for an experimental Revuforj combination regimen in patients with newly diagnosed AML.”

    From the U.S. healthcare business front,

    • Kaufman Hall reports
      • “The most recent National Hospital Flash Report highlights stabilizing hospital margins, with a persistent gap in hospital performance, according to September 2025 data. Year to date margins range from 14.7% for hospitals performing at the top quartile to -1.8% at the lowest quartile, with the 50th percentile at approximately 2.9% when adjusted for the allocations to hospitals from corporate, physician, and other entities.
      • “September saw also month-over-month and year-over-year increases in inpatient discharges, patient days and emergency department visits. With patient volumes moderately increasing year over year, the ability of hospitals to manage patient throughput efficiently is more important than ever.”
    • Kaufman Hall also offers advice to hospitals and payers about recent and potential site neutral payment developments.
    • Modern Healthcare points out,
      • “Prime Healthcare Foundation has decided not to acquire two Prospect Medical Holdings hospitals in Rhode Island. 
      • “Prospect Medical Holdings has filed a motion to close the facilities if a buyer is not found.”
    • Per Becker Payer Issues,
      • “This year, Elevance Health began covering doula care for members of some employer-sponsored health plans. Cynthia Brown, MD, medical director and clinical lead for women’s health at Elevance Health, joined the Becker’s Payer Issues podcast for an upcoming episode on her team’s push for doula coverage.”